Back to results

LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Primary Purpose

Heavy Menstrual Bleeding, Uterine Fibroid

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Relugolix

Estradiol/norethindrone acetate

Estradiol/norethindrone acetate placebo

Relugolix placebo

About this trial

This is an interventional treatment trial for Heavy Menstrual Bleeding focused on measuring Uterine Fibroid, Heavy Menstrual Bleeding, Menstrual Blood Volume

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Key Inclusion Criteria:

Premenopausal female aged 18 to 50 years old (inclusive) on the day of signing and dating the informed consent form.
Has regularly occurring menstrual periods of ≤ 14 days duration with a cycle of 21 to 38 days from the start of 1 menstrual period until the start of the next, by participant history for at least 3 months prior to the first screening visit.
Has a diagnosis of uterine fibroids that is confirmed by a transvaginal and/or transabdominal ultrasound performed during the screening period.
Has heavy menstrual bleeding associated with uterine fibroids as evidenced by an MBL of ≥ 160 milliliter (mL) during 1 cycle or ≥ 80 mL per cycle for 2 menstrual cycles as measured by the alkaline hematin method during the screening period.

Key Exclusion Criteria:

Has transvaginal and/or transabdominal ultrasound during the screening period demonstrating pathology other than uterine fibroids that could be responsible for or contributing to the patient's heavy menstrual bleeding.
Has known rapidly enlarging uterine fibroids in the opinion of the investigator.
Has a weight that exceeds the weight limit of the DXA scanner or has a condition that precludes an adequate DXA measurement at the lumbar spine and proximal femur.
Has a history of or currently has osteoporosis, or other metabolic bone disease, hyperparathyroidism, hyperprolactinemia, hyperthyroidism, anorexia nervosa, or low traumatic (from the standing position) or atraumatic fracture (toe, finger, skull, face and ankle fractures are allowed). A history of successfully treated hyperparathyroidism, hyperprolactinemia, or hyperthyroidism is allowed if the participant's bone mineral density is within normal limits.
Has a history of the use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, denosumab, or any medication other than calcium and vitamin D preparations to treat bone mineral density loss.
Has been a participant in an investigational drug or device study within the 1 month prior to the first screening visit.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Relugolix plus E2/NETA (Group A)

Relugolix plus Delayed E2/NETA (Group B)

Placebo (Group C)

Arm Description

Relugolix co-administered with E2/NETA for 24 weeks.

Relugolix co-administered with E2/NETA placebo for 12 weeks, followed by relugolix co-administered with E2/NETA for 12 weeks.

Relugolix placebo co-administered with E2/NETA placebo for 24 weeks.

Outcomes

Primary Outcome Measures

Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA

A responder was a participant who had MBL volume of < 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 24). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 24/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented. As per the objective of the study, the pre-specified primary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Secondary Outcome Measures

Percentage Of Participants With Amenorrhea Over The Last 35 Days Of Treatment

Amenorrhea was defined as meeting 1 of the following criteria for 2 consecutive visits: No feminine product returned due to reported amenorrhea; No feminine product returned due to reports of spotting/negligible bleeding coupled with electronic diary (eDiary) data indicating infrequent non-cyclic bleeding/spotting; Feminine product collection with a negligible observed MBL volume coupled with eDiary data indicating infrequent non-cyclic bleeding/spotting. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Percent Change From Baseline At Week 24 In MBL Volume

MBL volume was measured using the alkaline hematin method. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Percentage Of Participants With A Hemoglobin Level ≤ 10.5 g/dL At Baseline Who Achieved An Increase Of > 2 g/dL From Baseline At Week 24

Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin ≤ 10.5 gram (g)/deciliter (dL) at Baseline and reported at Week 24. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA with placebo arms are presented.

Percentage Of Participants With A Maximum NRS Score ≤ 1 For Uterine Fibroid-Associated Pain Over The Last 35 Days Of Treatment

Uterine fibroid-associated pain was assessed by a pain numerical rating scale (NRS). The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain). Participants were asked to document, in an e-Diary, the worst pain associated with their uterine fibroids that they experienced during the last 24 hours, every day until the end of study drug administration. Pain evaluable participants, defined as those who had maximum NRS score ≥ 4 at Baseline and had at least 28 days (80% of the last 35 days of treatment) of pain scores recorded in the e-Diary, were analyzed. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Percent Change From Baseline At Week 24 In Primary Uterine Fibroid Volume

The volume of the primary uterine fibroid was measured by transvaginal or transabdominal ultrasound. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Percent Change From Baseline At Week 24 In Uterine Volume

The volume of the uterus was measured by transvaginal or transabdominal ultrasound. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Change From Baseline At Week 24 In UFS-QoL Bleeding And Pelvic Discomfort Scale Score As Measured By The UFS-QoL (Q1, Q2, Q5)

The Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL) Bleeding and Pelvic Discomfort (BPD) Scale has been derived from the UFS-QoL Symptoms Scale. The scale consists of the following 3 symptoms proximal to uterine fibroids: Heavy bleeding during your menstrual period (Question [Q] 1), passing blood clots during your menstrual period (Q2), and feeling tightness or pressure in your pelvic area (Q5). raw scores were transformed to a normalized score: Transformed Score = [(Actual raw score - lowest possible raw score)/(Possible raw score range)] * 100 Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. As per the study objective, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only these two arms are presented.

Percent Change From Baseline At Week 12 In Bone Mineral Density At The Lumbar Spine (L1 To L4), As Assessed By DXA

Bone mineral density (BMD) was assessed by dual-energy x-ray absorptiometry (DXA) at the lumbar spine (L1, L2, L3, and L4) at Baseline and at Week 12. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD. As per the objective of the study, the pre-specified secondary analyses compared relugolix plus E2/NETA with relugolix plus delayed E2/NETA at Week 12 and are presented below.

Percent Change From Baseline At Week 24 In Bone Mineral Density At The Lumbar Spine (L1 To L4), Total Hip, And Femoral Neck

BMD was assessed by DXA at the lumbar spine (L1, L2, L3, and L4), total hip, and femoral neck at Baseline and at Week 24. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Percentage Of Participants Experiencing Vasomotor Symptoms Through Week 12

An adverse event was defined as an unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The preferred terms of hyperhidrosis, feeling hot, hot flush, night sweats, and flushing were combined to describe vasomotor symptoms. Participants with multiple events for a given preferred term were counted only once for each preferred term. Reported CI based on exact binomial 95% CI (Clopper-Pearson). As per the objective of the study, this secondary analysis compared relugolix plus E2/NETA with relugolix plus delayed E2/NETA at Week 12 and are presented below.

Percentage Of Participants Experiencing Vasomotor Symptoms Through Week 24

An adverse event was defined as an unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The preferred terms of hyperhidrosis, feeling hot, hot flush, night sweats, and flushing were combined to describe vasomotor symptoms. Participants with multiple events for a given preferred term were counted only once for each preferred term. Reported percentages based on the total number of participants in each treatment group. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Predose Trough Concentrations Of Relugolix And Norethindrone (NET) In The Relugolix Plus E2/NETA Group At Week 24

Blood samples for determination of relugolix and NET plasma concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology. Concentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented.

Predose Trough Concentrations Of E2 In The Relugolix Plus E2/NETA Group At Week 24

Blood samples for determination of E2 serum concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology. Concentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented.

Change From Baseline At Week 24 In Predose Concentrations Of Estradiol In The Relugolix Plus E2/NETA Group

Blood samples for determination of serum concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology. Concentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented.

Time To MBL Response

Defined as the time to achieve an MBL volume of < 80 mL and a ≥ 50% reduction from Baseline MBL volume as measured by the alkaline hematin method. MBL volume was measured using the alkaline hematin method. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Sustained Amenorrhea Rate (No Or Negligible Bleeding)

Sustained amenorrhea is defined as participants time to achieve and maintain amenorrhea until the date of last study drug. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Time To Achieving Sustained Amenorrhea (No Or Negligible Bleeding)

Sustained amenorrhea status as determined based on time to achieve and maintain amenorrhea status. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Time To Achieving Amenorrhea (No Or Negligible Bleeding)

Time to amenorrhea was defined as the weeks from date of first dose of study drug to the start of amenorrhea. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Number Of Participants With Hemoglobin ≤ 10.5 g/dL At Baseline And Achieved An Increase Of > 2 g/dL At Week 24

As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Percent Change From Baseline In Hemoglobin For Women With a Hemoglobin ≤ 10.5 g/dL At Baseline

LS means and p-value for test of difference is relugolix plus E2/NETA minus Placebo based on mixed-effect model with treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Number Of Participants With Hemoglobin Increase Of ≥ 1 g/dL From Baseline To Week 24 Among Those With Below Lower Limit Of Normal

As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Change From Baseline At Week 24 In The UFS-QoL Symptom Severity Scale Score

Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Change From Baseline At Week 24 In The UFS-QoL Activities Scale Score

Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Change From Baseline At Week 24 In The UFS-QoL Revised Activities Scale Score

Transformed score ranges from 0 to 100 based on Likert scale (none of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Change From Baseline In UFS-QoL Score By Health-Related Quality Of Life Total Score

The UFS-QoL total score was the sum of 6 subscales (concern, activities, energy/mood, control, self-conscious, and sexual function). The raw scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good). As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Number Of Responders With At Least 20 Points Increase From Baseline At Week 24 In UFS-QoL Revised Activities Scale Score

As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Change From Baseline In UFS-QoL Bleeding And Pelvic Discomfort Scale Score

The Bleeding and Pelvic Discomfort Scale consists of 3 items proximal to uterine fibroids that are experienced by most patients (heavy bleeding during the menstrual period [Question 1], passing blood clots during the menstrual period [Question 2], and feeling tightness or pressure in the pelvic area [Question 5]).Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Number Of Responders With At Least 20 Points Decrease In UFS-QoL Bleeding And Pelvic Discomfort Scale Score

A Responder was defined as meeting a meaningful change threshold, set as a 20-point change from Baseline, in the Bleeding And Pelvic Discomfort Scale at Week 24 on the transformed score. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Change From Baseline At Week 24 In The Interference Of Uterine Fibroids With Physical Activities Based On UFS-QoL Question 11

Change From Baseline At Week 24 In The Interference Of Uterine Fibroids With Social Activities Based On UFS-QoL Question 20

Change From Baseline At Week 24 In Embarrassment Caused By Uterine Fibroids Based On UFS-QoL Question 29

Change From Baseline At Week 24 In Symptoms Assessed Using The Patient Global Assessment (PGA) Questionnaire

The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all [1], mild limitation [2], moderate limitation [3], quite a bit of limitation [4], and extreme limitation [5]). As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Change From Baseline At Week 24 In Function Assessed Using The PGA Questionnaire

Participants Achieving Improvement From Baseline In The PGA Questionnaire For Symptoms From Baseline At Week 24

The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all [1], mild limitation [2], moderate limitation [3], quite a bit of limitation [4], and extreme limitation [5]). Category improvements for symptoms are presented. A 1-category improvement would be severe at baseline to moderate. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Participants Achieving Improvement From Baseline In The PGA Questionnaire For Uterine Fibroid-related Function From Baseline At Week 24

The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all [1], mild limitation [2], moderate limitation [3], quite a bit of limitation [4], and extreme limitation [5]). Category improvements for symptoms are presented. A 1-category improvement would be severe at baseline to moderate. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Change From Baseline At Week 24 In The Menorrhagia Impact Questionnaire Score For Physical Activities

The Menorrhagia Impact was evaluated using a 5-point response scale to assess level of improvement from Baseline to Week 24. Response scale: Not at all, 2. Slightly, 3.Moderately, 4. Quite a bit and 5. Extremely. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Change From Baseline At Week 24 In The Menorrhagia Impact Questionnaire Score For Social Activities

Number Of Participants Who Achieved A Maximum NRS Score ≤ 1 For Uterine Fibroid-associated Pain Over The Last 35 Days Of Treatment Who Had Maximum Pain Scores ≥ 4 During The 35 Days Prior To Randomization

Uterine fibroid-associated pain was assessed by a pain NRS. The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain). As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Number Of Participants With A ≥ 30% Reduction in NRS Score From Baseline to Last 35 Days of Treatment Who Had Maximum Pain Scores ≥ 4 At Baseline

Change From Baseline In Luteinizing Serum Concentration At Week 24

As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Change From Baseline In Follicle Stimulating Serum Concentration At Week 24

As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Change From Baseline In E2 Serum Concentration At Week 24

As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Change From Baseline In Progesterone Serum Concentration At Week 24

As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Full Information

NCT ID

NCT03049735

First Posted

February 8, 2017

Last Updated

March 23, 2022

Sponsor

Myovant Sciences GmbH

1. Study Identification

Unique Protocol Identification Number

NCT03049735

Brief Title

LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Official Title

LIBERTY 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

April 26, 2017 (Actual)

Primary Completion Date

April 29, 2019 (Actual)

Study Completion Date

August 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Myovant Sciences GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.

Detailed Description

This study is an international phase 3 randomized, double-blind, placebo-controlled efficacy and safety study to evaluate 24 weeks of oral daily relugolix 40 mg co-administered with low-dose E2 and NETA (Group A) and 12 weeks of daily oral relugolix 40 mg alone followed by 12 weeks of daily oral relugolix 40 mg co-administered with low-dose E2 and NETA (Group B) compared with 24 weeks of placebo (Group C). All participants completing the Week 24 visit, including women randomized to placebo, were offered the opportunity to enroll in an open-label extension study in which all eligible participants will receive relugolix co-administered with low-dose E2 and NETA. Participants who did not enroll into the extension study had a follow-up visit approximately 30 days after the end of treatment (that is, after the participant's last dose of study medication). Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms, and assessments of bone mineral density.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heavy Menstrual Bleeding, Uterine Fibroid

Keywords

Uterine Fibroid, Heavy Menstrual Bleeding, Menstrual Blood Volume

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

388 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Relugolix plus E2/NETA (Group A)

Arm Type

Experimental

Arm Description

Relugolix co-administered with E2/NETA for 24 weeks.

Arm Title

Relugolix plus Delayed E2/NETA (Group B)

Arm Type

Experimental

Arm Description

Relugolix co-administered with E2/NETA placebo for 12 weeks, followed by relugolix co-administered with E2/NETA for 12 weeks.

Arm Title

Placebo (Group C)

Arm Type

Placebo Comparator

Arm Description

Relugolix placebo co-administered with E2/NETA placebo for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

Relugolix

Other Intervention Name(s)

TAK-385, MVT-601

Intervention Description

Relugolix (40 mg) tablet administered orally once daily.

Intervention Type

Drug

Intervention Name(s)

Estradiol/norethindrone acetate

Other Intervention Name(s)

E2/NETA, low-dose hormonal add-back

Intervention Description

E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.

Intervention Type

Drug

Intervention Name(s)

Estradiol/norethindrone acetate placebo

Intervention Description

E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the capsule containing E2/NETA in size, shape, color, and odor.

Intervention Type

Drug

Intervention Name(s)

Relugolix placebo

Intervention Description

Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.

Primary Outcome Measure Information:

Title

Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA

Description

Time Frame

From Baseline up to last 35 days of treatment (up to Week 24)

Secondary Outcome Measure Information:

Title

Percentage Of Participants With Amenorrhea Over The Last 35 Days Of Treatment

Description

Time Frame

From Baseline up to last 35 days of treatment (up to Week 24)

Title

Percent Change From Baseline At Week 24 In MBL Volume

Description

Time Frame

Baseline, Week 24

Title

Percentage Of Participants With A Hemoglobin Level ≤ 10.5 g/dL At Baseline Who Achieved An Increase Of > 2 g/dL From Baseline At Week 24

Description

Time Frame

From Baseline up to Week 24

Title

Percentage Of Participants With A Maximum NRS Score ≤ 1 For Uterine Fibroid-Associated Pain Over The Last 35 Days Of Treatment

Description

Time Frame

From Baseline up to Week 24

Title

Percent Change From Baseline At Week 24 In Primary Uterine Fibroid Volume

Description

Time Frame

Baseline, Week 24

Title

Percent Change From Baseline At Week 24 In Uterine Volume

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline At Week 24 In UFS-QoL Bleeding And Pelvic Discomfort Scale Score As Measured By The UFS-QoL (Q1, Q2, Q5)

Description

Time Frame

Baseline, Week 24

Title

Percent Change From Baseline At Week 12 In Bone Mineral Density At The Lumbar Spine (L1 To L4), As Assessed By DXA

Description

Time Frame

Baseline, Week 12

Title

Percent Change From Baseline At Week 24 In Bone Mineral Density At The Lumbar Spine (L1 To L4), Total Hip, And Femoral Neck

Description

Time Frame

Baseline, Week 24

Title

Percentage Of Participants Experiencing Vasomotor Symptoms Through Week 12

Description

Time Frame

Baseline through Week 12

Title

Percentage Of Participants Experiencing Vasomotor Symptoms Through Week 24

Description

An adverse event was defined as an unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The preferred terms of hyperhidrosis, feeling hot, hot flush, night sweats, and flushing were combined to describe vasomotor symptoms. Participants with multiple events for a given preferred term were counted only once for each preferred term. Reported percentages based on the total number of participants in each treatment group. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Time Frame

Baseline through Week 24

Title

Predose Trough Concentrations Of Relugolix And Norethindrone (NET) In The Relugolix Plus E2/NETA Group At Week 24

Description

Time Frame

Week 24

Title

Predose Trough Concentrations Of E2 In The Relugolix Plus E2/NETA Group At Week 24

Description

Time Frame

Week 24

Title

Change From Baseline At Week 24 In Predose Concentrations Of Estradiol In The Relugolix Plus E2/NETA Group

Description

Time Frame

Baseline, Week 24

Title

Time To MBL Response

Description

Time Frame

From Baseline through Week 24

Title

Sustained Amenorrhea Rate (No Or Negligible Bleeding)

Description

Time Frame

Week 24

Title

Time To Achieving Sustained Amenorrhea (No Or Negligible Bleeding)

Description

Time Frame

From Baseline through Week 24

Title

Time To Achieving Amenorrhea (No Or Negligible Bleeding)

Description

Time Frame

From Baseline through Week 24

Title

Number Of Participants With Hemoglobin ≤ 10.5 g/dL At Baseline And Achieved An Increase Of > 2 g/dL At Week 24

Description

As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Time Frame

From Baseline through Week 24

Title

Percent Change From Baseline In Hemoglobin For Women With a Hemoglobin ≤ 10.5 g/dL At Baseline

Description

Time Frame

Week 24

Title

Number Of Participants With Hemoglobin Increase Of ≥ 1 g/dL From Baseline To Week 24 Among Those With Below Lower Limit Of Normal

Description

As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Time Frame

Week 24

Title

Change From Baseline At Week 24 In The UFS-QoL Symptom Severity Scale Score

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline At Week 24 In The UFS-QoL Activities Scale Score

Description

Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Time Frame

Baseline, Week 24

Title

Change From Baseline At Week 24 In The UFS-QoL Revised Activities Scale Score

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline In UFS-QoL Score By Health-Related Quality Of Life Total Score

Description

Time Frame

Baseline, Week 24

Title

Number Of Responders With At Least 20 Points Increase From Baseline At Week 24 In UFS-QoL Revised Activities Scale Score

Description

As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Time Frame

From Baseline through Week 24

Title

Change From Baseline In UFS-QoL Bleeding And Pelvic Discomfort Scale Score

Description

Time Frame

Baseline, Week 24

Title

Number Of Responders With At Least 20 Points Decrease In UFS-QoL Bleeding And Pelvic Discomfort Scale Score

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline At Week 24 In The Interference Of Uterine Fibroids With Physical Activities Based On UFS-QoL Question 11

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline At Week 24 In The Interference Of Uterine Fibroids With Social Activities Based On UFS-QoL Question 20

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline At Week 24 In Embarrassment Caused By Uterine Fibroids Based On UFS-QoL Question 29

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline At Week 24 In Symptoms Assessed Using The Patient Global Assessment (PGA) Questionnaire

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline At Week 24 In Function Assessed Using The PGA Questionnaire

Description

Time Frame

Baseline, Week 24

Title

Participants Achieving Improvement From Baseline In The PGA Questionnaire For Symptoms From Baseline At Week 24

Description

The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all [1], mild limitation [2], moderate limitation [3], quite a bit of limitation [4], and extreme limitation [5]). Category improvements for symptoms are presented. A 1-category improvement would be severe at baseline to moderate. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Time Frame

From Baseline through Week 24

Title

Participants Achieving Improvement From Baseline In The PGA Questionnaire For Uterine Fibroid-related Function From Baseline At Week 24

Description

The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all [1], mild limitation [2], moderate limitation [3], quite a bit of limitation [4], and extreme limitation [5]). Category improvements for symptoms are presented. A 1-category improvement would be severe at baseline to moderate. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Time Frame

From Baseline through Week 24

Title

Change From Baseline At Week 24 In The Menorrhagia Impact Questionnaire Score For Physical Activities

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline At Week 24 In The Menorrhagia Impact Questionnaire Score For Social Activities

Description

Time Frame

Baseline, Week 24

Title

Description

Time Frame

From Baseline up to the last 35 days of treatment (up to 24 weeks)

Title

Number Of Participants With A ≥ 30% Reduction in NRS Score From Baseline to Last 35 Days of Treatment Who Had Maximum Pain Scores ≥ 4 At Baseline

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline In Luteinizing Serum Concentration At Week 24

Description

As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Time Frame

Baseline, Week 24

Title

Change From Baseline In Follicle Stimulating Serum Concentration At Week 24

Description

As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Time Frame

Baseline, Week 24

Title

Change From Baseline In E2 Serum Concentration At Week 24

Description

As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Time Frame

Baseline, Week 24

Title

Change From Baseline In Progesterone Serum Concentration At Week 24

Description

As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.

Time Frame

Baseline, Week 24

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Premenopausal female aged 18 to 50 years old (inclusive) on the day of signing and dating the informed consent form. Has regularly occurring menstrual periods of ≤ 14 days duration with a cycle of 21 to 38 days from the start of 1 menstrual period until the start of the next, by participant history for at least 3 months prior to the first screening visit. Has a diagnosis of uterine fibroids that is confirmed by a transvaginal and/or transabdominal ultrasound performed during the screening period. Has heavy menstrual bleeding associated with uterine fibroids as evidenced by an MBL of ≥ 160 milliliter (mL) during 1 cycle or ≥ 80 mL per cycle for 2 menstrual cycles as measured by the alkaline hematin method during the screening period. Key Exclusion Criteria: Has transvaginal and/or transabdominal ultrasound during the screening period demonstrating pathology other than uterine fibroids that could be responsible for or contributing to the patient's heavy menstrual bleeding. Has known rapidly enlarging uterine fibroids in the opinion of the investigator. Has a weight that exceeds the weight limit of the DXA scanner or has a condition that precludes an adequate DXA measurement at the lumbar spine and proximal femur. Has a history of or currently has osteoporosis, or other metabolic bone disease, hyperparathyroidism, hyperprolactinemia, hyperthyroidism, anorexia nervosa, or low traumatic (from the standing position) or atraumatic fracture (toe, finger, skull, face and ankle fractures are allowed). A history of successfully treated hyperparathyroidism, hyperprolactinemia, or hyperthyroidism is allowed if the participant's bone mineral density is within normal limits. Has a history of the use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, denosumab, or any medication other than calcium and vitamin D preparations to treat bone mineral density loss. Has been a participant in an investigational drug or device study within the 1 month prior to the first screening visit.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Myovant Medical Monitor

Organizational Affiliation

Myovant Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Andalusia

City

Andalusia

State/Province

Alabama

ZIP/Postal Code

36420

Country

United States

Facility Name

Mobile

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Little Rock

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

La Mesa

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Lomita

City

Lomita

State/Province

California

ZIP/Postal Code

90717

Country

United States

Facility Name

Norwalk

City

Norwalk

State/Province

California

ZIP/Postal Code

90650

Country

United States

Facility Name

Oceanside

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92111

Country

United States

Facility Name

Denver

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

Facility Name

Aventura

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Brandon

City

Brandon

State/Province

Florida

ZIP/Postal Code

33510

Country

United States

Facility Name

Clearwater

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33759

Country

United States

Facility Name

Clermont

City

Clermont

State/Province

Florida

ZIP/Postal Code

34711

Country

United States

Facility Name

Fort Myers

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

Facility Name

Hialeah

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Hialeah

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Jacksonville

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

Lauderdale Lakes

City

Lauderdale Lakes

State/Province

Florida

ZIP/Postal Code

33319

Country

United States

Facility Name

Margate

City

Margate

State/Province

Florida

ZIP/Postal Code

33063

Country

United States

Facility Name

Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Orlando

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Orlando

City

Orlando

State/Province

Florida

ZIP/Postal Code

32808

Country

United States

Facility Name

Palm Harbor

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

South Miami

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Tampa

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

West Palm Beach

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

Weston

City

Weston

State/Province

Florida

ZIP/Postal Code

33327

Country

United States

Facility Name

Atlanta

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Atlanta

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

49074

Country

United States

Facility Name

Augusta

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

College Park

City

College Park

State/Province

Georgia

ZIP/Postal Code

30349

Country

United States

Facility Name

Richland

City

Richland

State/Province

Georgia

ZIP/Postal Code

99352

Country

United States

Facility Name

Oakbrook

City

Oakbrook Terrace

State/Province

Illinois

ZIP/Postal Code

60523

Country

United States

Facility Name

Lafayette

City

Lafayette

State/Province

Indiana

ZIP/Postal Code

47905

Country

United States

Facility Name

Covington

City

Covington

State/Province

Louisiana

ZIP/Postal Code

70433

Country

United States

Facility Name

Shreveport

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71118

Country

United States

Facility Name

St. Louis

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Lincoln

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

Country

United States

Facility Name

Omaha

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68124

Country

United States

Facility Name

Las Vegas

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Las Vegas

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Lawrenceville

City

Lawrenceville

State/Province

New Jersey

ZIP/Postal Code

08648

Country

United States

Facility Name

Albuquerque

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

Williamsville

City

Williamsville

State/Province

New York

ZIP/Postal Code

14221

Country

United States

Facility Name

Durham

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27713

Country

United States

Facility Name

Morehead City

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557

Country

United States

Facility Name

Raleigh

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Bismarck

City

Bismarck

State/Province

North Dakota

ZIP/Postal Code

58501

Country

United States

Facility Name

Fargo

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Minot

City

Minot

State/Province

North Dakota

ZIP/Postal Code

58701

Country

United States

Facility Name

Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

Dayton

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45409

Country

United States

Facility Name

Englewood

City

Englewood

State/Province

Ohio

ZIP/Postal Code

45322

Country

United States

Facility Name

Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Bluffton

City

Bluffton

State/Province

South Carolina

ZIP/Postal Code

29910

Country

United States

Facility Name

Charleston

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Columbia

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29201

Country

United States

Facility Name

Greenville

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Facility Name

Chattanooga

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Memphis

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Memphis

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

Fort Worth

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

Facility Name

Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Irving

City

Irving

State/Province

Texas

ZIP/Postal Code

75062

Country

United States

Facility Name

San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Sugar Land

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

Webster

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Salt Lake City

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Salt Lake City

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

Facility Name

Norfolk

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Seattle

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Curitiba

City

Curitiba

ZIP/Postal Code

80430-160

Country

Brazil

Facility Name

Porto Alegre

City

Porto Alegre

ZIP/Postal Code

90510-040

Country

Brazil

Facility Name

Ribeirao Preto

City

Ribeirão Preto

ZIP/Postal Code

14049-900

Country

Brazil

Facility Name

Santo Andre

City

Santo André

ZIP/Postal Code

09190-510

Country

Brazil

Facility Name

Sao Paulo

City

São Paulo

ZIP/Postal Code

01317-000

Country

Brazil

Facility Name

Bologna

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Catanzaro

City

Catanzaro

ZIP/Postal Code

88100

Country

Italy

Facility Name

Fiernze

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Genova

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Milano

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Modena

City

Modena

ZIP/Postal Code

41124

Country

Italy

Facility Name

Monserrato

City

Monserrato

ZIP/Postal Code

09042

Country

Italy

Facility Name

Napoli

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Roma

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

Roma

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Siena

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Torino

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Katowice

City

Katowice

ZIP/Postal Code

40-123

Country

Poland

Facility Name

Lublin

City

Lublin

ZIP/Postal Code

20-093

Country

Poland

Facility Name

Lublin

City

Lublin

ZIP/Postal Code

20-632

Country

Poland

Facility Name

Poznan

City

Poznań

ZIP/Postal Code

60-535

Country

Poland

Facility Name

Szczecin

City

Szczecin

ZIP/Postal Code

71-270

Country

Poland

Facility Name

Warszawa

City

Warszawa

ZIP/Postal Code

02-201

Country

Poland

Facility Name

Warszawa

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Lodz

City

Łódź

ZIP/Postal Code

90-602

Country

Poland

Facility Name

Lodz

City

Łódź

ZIP/Postal Code

91-308

Country

Poland

Facility Name

Durban

City

Durban

ZIP/Postal Code

4052

Country

South Africa

Facility Name

Durban

City

Durban

ZIP/Postal Code

4126

Country

South Africa

Facility Name

Port Elizabeth

City

Port Elizabeth

ZIP/Postal Code

6001

Country

South Africa

Facility Name

Roodepoort

City

Roodepoort

ZIP/Postal Code

1724

Country

South Africa

Facility Name

Birmingham

City

Birmingham

ZIP/Postal Code

B15 2TG

Country

United Kingdom

Facility Name

Isleworth

City

Isleworth

ZIP/Postal Code

TW7 6AF

Country

United Kingdom

Facility Name

London

City

London

ZIP/Postal Code

SE5 9NY

Country

United Kingdom

Facility Name

Nottingham

City

Nottingham

ZIP/Postal Code

NG7 2FT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36357960

Citation

Al-Hendy A, Lukes AS, Poindexter AN 3rd, Venturella R, Villarroel C, McKain L, Li Y, Wagman RB, Stewart EA. Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas. Obstet Gynecol. 2022 Dec 1;140(6):920-930. doi: 10.1097/AOG.0000000000004988. Epub 2022 Nov 2.

Results Reference

derived

PubMed Identifier

35675604

Citation

Stewart EA, Lukes AS, Venturella R, Arjona Ferreira JC, Li Y, Hunsche E, Wagman RB, Al-Hendy A. Relugolix Combination Therapy for Uterine Leiomyoma-Associated Pain in the LIBERTY Randomized Trials. Obstet Gynecol. 2022 Jun 1;139(6):1070-1081. doi: 10.1097/AOG.0000000000004787. Epub 2022 May 2. Erratum In: Obstet Gynecol. 2022 Jul 1;140(1):138.

Results Reference

derived

PubMed Identifier

35415708

Citation

Hunsche E, Rakov V, Scippa K, Witherspoon B, McKain L. The Burden of Uterine Fibroids from the Perspective of US Women Participating in Open-Ended Interviews. Womens Health Rep (New Rochelle). 2022 Mar 4;3(1):286-296. doi: 10.1089/whr.2021.0086. eCollection 2022.

Results Reference

derived

PubMed Identifier

33596357

Citation

Al-Hendy A, Lukes AS, Poindexter AN 3rd, Venturella R, Villarroel C, Critchley HOD, Li Y, McKain L, Arjona Ferreira JC, Langenberg AGM, Wagman RB, Stewart EA. Treatment of Uterine Fibroid Symptoms with Relugolix Combination Therapy. N Engl J Med. 2021 Feb 18;384(7):630-642. doi: 10.1056/NEJMoa2008283.

Results Reference

derived

Learn more about this trial

LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

We'll reach out to this number within 24 hrs

LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Heavy Menstrual Bleeding, Uterine Fibroid

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial