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A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis

Primary Purpose

Uterine Fibroids, Endometriosis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Relugolix Combination Tablet
Sponsored by
Myovant Sciences GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring Uterine Leiomyomas, Fibroids, Endometriosis, Bone Mineral Density, Relugolix, Estradiol, Norethindrone acetate

Eligibility Criteria

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

Key Inclusion Criteria: Is a premenopausal woman, 18 to 50 years of age (inclusive); A diagnosis of uterine fibroids confirmed by imaging or review of medical records and reports heavy menstrual bleeding negatively affecting quality of life. or A diagnosis of endometriosis that is associated with moderate to severe pain.; If at risk of pregnancy is willing to avoid pregnancy for 4 years (the duration of the treatment period) using nonhormonal methods of contraception. Has a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the allocation visit (or Month 12 if entering from MVT-601-050 [NCT04756037; SERENE]); In good physical and mental health based on medical, surgical, and gynecological history as well as physical, gynecological, and breast examinations, clinical laboratory test results, and vital sign measurements; Has a body mass index ≥ 18 kg/m^2. Key Exclusion Criteria: Has a weight or body habitus that exceeds the limit of the DXA scanner or has a condition that precludes an adequate DXA measurement at the lumbar spine or proximal femur Has a DXA result demonstrating the following criteria at any anatomic site (lumbar spine, total hip, femoral neck): For patients entering de novo a Z-score ≤ -1.5 or T-score ≤ -2.0 (if ≥ 40 years of age) For patients entering from MVT-601-050 (NCT04756037; SERENE) a 12-month on-treatment DXA demonstrating Z-score ≤ -2.0, T-score ≤ -2.5 (if ≥ 40 years of age), or BMD loss ≥ 8% compared with pre-treatment baseline; Screening 25-OH vitamin D level < 12 ng/mL (patients with 25-OH vitamin D deficiency with levels ≥ 12 to < 20 ng/mL are permitted if supplementing with vitamin D or if vitamin D supplementation is started in the screening period); Has a history of or currently has Cushing's Syndrome, Rheumatoid Arthritis, metabolic bone disease, uncorrected hyperparathyroidism, Paget's disease of the bone, collagen vascular disease, Marfan's syndrome, Ehlers-Danlos syndrome (if confirmed on genetic testing or meets definitive criteria for hypermobility type), chronic kidney disease (CKD) stage 3 or greater with glomerular filtration rate (GFR) < 60 mL/min/m2 using Modification of Diet in Renal Disease (MDRD) method, hyperprolactinemia, known pituitary adenoma, hyperthyroidism, anorexia nervosa, bulimia (within the last year), abnormal bone mineral metabolism (eg, hypophosphatemia). Patients whose hyperparathyroidism or hyperthyroidism has been successfully treated or whose hyperprolactinemia has been successfully treated are allowed; History of low trauma (fragility) fracture. Past history of use or current use of medication used to treat bone loss other than calcium and vitamin D preparations; Prior use of depot-medroxyprogesterone acetate for a treatment period > 2 years (if treatment occurred within the past 5 years) or prior use of GnRH agonist or antagonist for > 12 months total (unless directly entering from MVT-601-050 [NCT04756037; SERENE]); Malabsorptive disease (including, but not limited to, inflammatory bowel disease and gastric bypass surgery); Current breast cancer, history of breast cancer or other hormone-sensitive malignancy, at increased risk for hormone-sensitive malignancy, or taking an aromatase inhibitor for breast cancer treatment or prevention History of organ transplantation or history of bone marrow BIRADS ≥ 3 Mammogram at entry (or within the past 6 months). Has a known human immunodeficiency virus (HIV) infection or at high risk of contracting HIV Has a current psychiatric disorder that would, in the investigator or medical monitor's opinion, impair the ability of the patient to participate in the study or would impair interpretation of their data. Is currently using a hormonal intrauterine device or contraceptive implant, hormonal contraceptive, or other prohibited medication and is unwilling to discontinue this hormonal contraception

Sites / Locations

  • MobileRecruiting
  • ChandlerRecruiting
  • MesaRecruiting
  • PhoenixRecruiting
  • Canoga ParkRecruiting
  • WashingtonRecruiting
  • AventuraRecruiting
  • HialeahRecruiting
  • Lake WorthRecruiting
  • MiamiRecruiting
  • MiamiRecruiting
  • New Port RicheyRecruiting
  • OrlandoRecruiting
  • Panama CityRecruiting
  • VeniceRecruiting
  • AtlantaRecruiting
  • NorcrossRecruiting
  • SmyrnaRecruiting
  • Idaho FallsRecruiting
  • ShawneeRecruiting
  • WichitaRecruiting
  • MarreroRecruiting
  • MetairieRecruiting
  • Las VegasRecruiting
  • North Las VegasRecruiting
  • DurhamRecruiting
  • RaleighRecruiting
  • EnglewoodRecruiting
  • ErieRecruiting
  • PhiladelphiaRecruiting
  • ChattanoogaRecruiting
  • MemphisRecruiting
  • MemphisRecruiting
  • HoustonRecruiting
  • HoustonRecruiting
  • San AntonioRecruiting
  • Newport NewsRecruiting
  • NorfolkRecruiting
  • RestonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Relugolix Combination Tablet

Arm Description

Participants will receive relugolix combination therapy orally once daily for 48 months.

Outcomes

Primary Outcome Measures

Percent change from baseline in BMD (bone mineral density) at Month 48 on-treatment at lumbar spine (L1-L4) in women with uterine fibroids.
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in women with endometriosis.
Assessed by dual-energy X-ray absorptiometry (DXA) scan.

Secondary Outcome Measures

Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in women with uterine fibroids.
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in women with endometriosis.
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in the overall study population.
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in the overall study population.
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Percent change from baseline in BMD at post-treatment follow-up (PTFU) Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Percent change from baseline in BMD at PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Percent change from baseline in BMD at PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Incidence of treatment-emergent serious adverse events, and non-serious adverse events leading to treatment discontinuation or withdrawal from the study during the 48 months of treatment.
Safety analyses will be conducted using the safety populations for women with uterine fibroids, women with endometriosis, and overall population. The treatment-emergent period will be defined as the period of time from the date of the first dose of the study drug through 14 days after the last dose of study drug, or the date of initiation of another investigational agent or hormonal therapy affecting the hypothalamic-pituitary gonadal axis or surgical intervention for uterine fibroids or for endometriosis, whichever occurs first.
Incidence and location of fractures during the 48 months on treatment and 12 months PTFU.
Safety analyses will be conducted using the safety populations for women with uterine fibroids, women with endometriosis, and overall population. All adverse events will be coded to preferred term and system organ class using Medical Dictionary for Regulatory Activities (MedDRA) version 24.0 or higher. The incidence of fractures will also be summarized by anatomical sites and whether the fracture qualifies as a fragility fracture. A participant reporting the same adverse event more than once is counted once, and at the maximum severity or strongest relationship to study drug treatment when calculating incidence.

Full Information

First Posted
May 8, 2023
Last Updated
October 10, 2023
Sponsor
Myovant Sciences GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05862272
Brief Title
A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis
Official Title
A Phase 3B, Single-Arm, Open-Label Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids or Moderate to Severe Pain Associated With Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2023 (Actual)
Primary Completion Date
July 2029 (Anticipated)
Study Completion Date
September 2030 (Anticipated)

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
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or with moderate-to-severe pain associated with endometriosis.
Detailed Description
A prospective, single-arm, open-label, Phase 3B study to assess the effect of continuous 48 months (4 years) of treatment with relugolix combination tablet (relugolix 40 mg/estradiol [E2] 1 mg/norethindrone acetate [NETA] 0.5 mg) on bone mineral density in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) and premenopausal women with moderate to severe pain associated with endometriosis. Approximately 1000 women (500 with heavy menstrual bleeding associated with uterine fibroids and 500 with moderate to severe pain associated with endometriosis) will receive relugolix combination tablet, during which time BMD will be assessed by dual-energy X-ray absorptiometry every 6 months. A subset of participants will be eligible to enter this study following completion of 1 year of treatment with relugolix combination therapy in MVT-601-050 (NCT04756037; SERENE) and will complete 3 years of treatment under this protocol. Upon completion of 48 months (4 years) of treatment or after early termination of treatment, participants will enter a 1-year post-treatment follow-up period during which time bone mineral density will be assessed at Month 6 and Month 12 following treatment cessation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Endometriosis
Keywords
Uterine Leiomyomas, Fibroids, Endometriosis, Bone Mineral Density, Relugolix, Estradiol, Norethindrone acetate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Relugolix Combination Tablet
Arm Type
Experimental
Arm Description
Participants will receive relugolix combination therapy orally once daily for 48 months.
Intervention Type
Drug
Intervention Name(s)
Relugolix Combination Tablet
Other Intervention Name(s)
TAK-385, T-1331285, RVT-601, MVT-601, MVT-601A, MYFEMBREE
Intervention Description
A fixed-dose combination tablet containing relugolix 40 mg, estradiol (E2) 1 mg, and norethindrone acetate (NETA) 0.5 mg.
Primary Outcome Measure Information:
Title
Percent change from baseline in BMD (bone mineral density) at Month 48 on-treatment at lumbar spine (L1-L4) in women with uterine fibroids.
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Time Frame
Baseline up to Month 48
Title
Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in women with endometriosis.
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Time Frame
Baseline up to Month 48
Secondary Outcome Measure Information:
Title
Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in women with uterine fibroids.
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Time Frame
Baseline up to Month 48
Title
Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in women with endometriosis.
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Time Frame
Baseline up to Month 48
Title
Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Time Frame
Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
Title
Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Time Frame
Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
Title
Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in the overall study population.
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Time Frame
Baseline up to Month 48
Title
Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in the overall study population.
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Time Frame
Baseline up to Month 48
Title
Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Time Frame
Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
Title
Percent change from baseline in BMD at post-treatment follow-up (PTFU) Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Time Frame
6 months and 12 months post treatment
Title
Percent change from baseline in BMD at PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Time Frame
6 months and 12 months post treatment
Title
Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Time Frame
6 months and 12 months post treatment
Title
Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Time Frame
6 months and 12 months post treatment
Title
Percent change from baseline in BMD at PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Time Frame
6 months and 12 months post treatment
Title
Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
Time Frame
6 months and 12 months post treatment
Title
Incidence of treatment-emergent serious adverse events, and non-serious adverse events leading to treatment discontinuation or withdrawal from the study during the 48 months of treatment.
Description
Safety analyses will be conducted using the safety populations for women with uterine fibroids, women with endometriosis, and overall population. The treatment-emergent period will be defined as the period of time from the date of the first dose of the study drug through 14 days after the last dose of study drug, or the date of initiation of another investigational agent or hormonal therapy affecting the hypothalamic-pituitary gonadal axis or surgical intervention for uterine fibroids or for endometriosis, whichever occurs first.
Time Frame
Baseline up to Month 48
Title
Incidence and location of fractures during the 48 months on treatment and 12 months PTFU.
Description
Safety analyses will be conducted using the safety populations for women with uterine fibroids, women with endometriosis, and overall population. All adverse events will be coded to preferred term and system organ class using Medical Dictionary for Regulatory Activities (MedDRA) version 24.0 or higher. The incidence of fractures will also be summarized by anatomical sites and whether the fracture qualifies as a fragility fracture. A participant reporting the same adverse event more than once is counted once, and at the maximum severity or strongest relationship to study drug treatment when calculating incidence.
Time Frame
Baseline up to Month 48 and 12 months post treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Is a premenopausal woman, 18 to 50 years of age (inclusive); A diagnosis of uterine fibroids confirmed by imaging or review of medical records and reports heavy menstrual bleeding negatively affecting quality of life. or A diagnosis of endometriosis that is associated with moderate to severe pain.; If at risk of pregnancy is willing to avoid pregnancy for 4 years (the duration of the treatment period) using nonhormonal methods of contraception. Has a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the allocation visit (or Month 12 if entering from MVT-601-050 [NCT04756037; SERENE]); In good physical and mental health based on medical, surgical, and gynecological history as well as physical, gynecological, and breast examinations, clinical laboratory test results, and vital sign measurements; Has a body mass index ≥ 18 kg/m^2. Key Exclusion Criteria: Has a weight or body habitus that exceeds the limit of the DXA scanner or has a condition that precludes an adequate DXA measurement at the lumbar spine or proximal femur Has a DXA result demonstrating the following criteria at any anatomic site (lumbar spine, total hip, femoral neck): For patients entering de novo a Z-score ≤ -1.5 or T-score ≤ -2.0 (if ≥ 40 years of age) For patients entering from MVT-601-050 (NCT04756037; SERENE) a 12-month on-treatment DXA demonstrating Z-score ≤ -2.0, T-score ≤ -2.5 (if ≥ 40 years of age), or BMD loss ≥ 8% compared with pre-treatment baseline; Screening 25-OH vitamin D level < 12 ng/mL (patients with 25-OH vitamin D deficiency with levels ≥ 12 to < 20 ng/mL are permitted if supplementing with vitamin D or if vitamin D supplementation is started in the screening period); Has a history of or currently has Cushing's Syndrome, Rheumatoid Arthritis, metabolic bone disease, uncorrected hyperparathyroidism, Paget's disease of the bone, collagen vascular disease, Marfan's syndrome, Ehlers-Danlos syndrome (if confirmed on genetic testing or meets definitive criteria for hypermobility type), chronic kidney disease (CKD) stage 3 or greater with glomerular filtration rate (GFR) < 60 mL/min/m2 using Modification of Diet in Renal Disease (MDRD) method, hyperprolactinemia, known pituitary adenoma, hyperthyroidism, anorexia nervosa, bulimia (within the last year), abnormal bone mineral metabolism (eg, hypophosphatemia). Patients whose hyperparathyroidism or hyperthyroidism has been successfully treated or whose hyperprolactinemia has been successfully treated are allowed; History of low trauma (fragility) fracture. Past history of use or current use of medication used to treat bone loss other than calcium and vitamin D preparations; Prior use of depot-medroxyprogesterone acetate for a treatment period > 2 years (if treatment occurred within the past 5 years) or prior use of GnRH agonist or antagonist for > 12 months total (unless directly entering from MVT-601-050 [NCT04756037; SERENE]); Malabsorptive disease (including, but not limited to, inflammatory bowel disease and gastric bypass surgery); Current breast cancer, history of breast cancer or other hormone-sensitive malignancy, at increased risk for hormone-sensitive malignancy, or taking an aromatase inhibitor for breast cancer treatment or prevention History of organ transplantation or history of bone marrow BIRADS ≥ 3 Mammogram at entry (or within the past 6 months). Has a known human immunodeficiency virus (HIV) infection or at high risk of contracting HIV Has a current psychiatric disorder that would, in the investigator or medical monitor's opinion, impair the ability of the patient to participate in the study or would impair interpretation of their data. Is currently using a hormonal intrauterine device or contraceptive implant, hormonal contraceptive, or other prohibited medication and is unwilling to discontinue this hormonal contraception
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials at Myovant
Phone
650-278-8743
Email
ClinicalTrials@Myovant.com
Facility Information:
Facility Name
Mobile
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Individual Site Status
Recruiting
Facility Name
Chandler
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Name
Mesa
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85209
Country
United States
Individual Site Status
Recruiting
Facility Name
Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Individual Site Status
Recruiting
Facility Name
Canoga Park
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
02011
Country
United States
Individual Site Status
Recruiting
Facility Name
Aventura
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Name
Hialeah
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Lake Worth
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
New Port Richey
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Individual Site Status
Recruiting
Facility Name
Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
Panama City
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Individual Site Status
Recruiting
Facility Name
Venice
City
Venice
State/Province
Florida
ZIP/Postal Code
34285
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Name
Norcross
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30093
Country
United States
Individual Site Status
Recruiting
Facility Name
Smyrna
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30082
Country
United States
Individual Site Status
Recruiting
Facility Name
Idaho Falls
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Name
Shawnee
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Individual Site Status
Recruiting
Facility Name
Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67211
Country
United States
Individual Site Status
Recruiting
Facility Name
Marrero
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
Metairie
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Individual Site Status
Recruiting
Facility Name
Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Recruiting
Facility Name
North Las Vegas
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Individual Site Status
Recruiting
Facility Name
Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Individual Site Status
Recruiting
Facility Name
Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Recruiting
Facility Name
Englewood
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Individual Site Status
Recruiting
Facility Name
Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507-1423
Country
United States
Individual Site Status
Recruiting
Facility Name
Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Individual Site Status
Recruiting
Facility Name
Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Recruiting
Facility Name
Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Name
Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77021
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Name
San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Individual Site Status
Recruiting
Facility Name
Newport News
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Individual Site Status
Recruiting
Facility Name
Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
Reston
City
Reston
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis

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