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Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain (RAQUEL)

Primary Purpose

Endometriosis-related Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Quinagolide 360 µg
Quinagolide 720 µg
Quinagolide 1080 µg
Placebo
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis-related Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pre-menopausal females aged ≥18 years at time of signing informed consent(s).
  • Body mass index (BMI) of 18-42 kg/m2 (both inclusive) at screening.
  • Initial confirmation of endometriosis by laparoscopy or laparotomy within the last 10 years before the run-in visit or visualization of persistent endometrioma by repeat ultrasound.
  • Transvaginal ultrasound documenting a uterus with no clinically significant abnormalities and presence of at least one ovary with no clinically significant abnormalities (with the exception of endometrioma) at the run-in visit.
  • Having moderate to severe endometriosis-related pain.
  • Willing to use a non-hormonal barrier method (i.e. condom) for contraception from randomization to the end-of-trial. This is not required if adequate contraception is achieved by vasectomy of the sexual partner or surgical sterilisation of the subject.
  • Willing to avoid the use of vaginal douches or any other intravaginally administered medications or devices from randomization to the end of treatment.
  • Willing to change usual analgesics to rescue analgesics as permitted by protocol for endometriosis-related pain from the start of run-in to the end-of-trial.

Exclusion Criteria:

  • Use of depot medroxyprogesterone acetate (MPA) within 10 months of the start of run-in.
  • Use of gonadotropin releasing hormone (GnRH) agonists (3 months depot) or dopamine agonists within 6 months of the start of run-in.
  • Use of GnRH agonists (1 month depot) or intrauterine device within 3 months of the start of run-in.
  • Use of GnRH antagonist, combined oral contraceptive pill or progestin-only pill within 1 month of the start of run-in.
  • Undiagnosed abnormal vaginal bleeding.
  • History of no relief of endometriosis related pain after any medical therapy or surgery. However, history of partial pain relief, discontinuation due to side effects are not exclusionary.
  • Known bone diseases (e.g. osteoporosis, Paget's disease and osteomalacia) affecting bone resorption or bone formation markers.
  • Any significant abnormal findings of heart examinations before randomization.

Sites / Locations

  • Marchand Institute for Minimally Invasive Surgery
  • Arkansas Primary Care Clinic
  • Medical Center for Clinical Research
  • UConn Health Lowell P Weicker Jr Clinical Research Center
  • Yale Fertility Center
  • Omega Research Consultants
  • South Florida Research Center
  • Florida Research Center
  • Miami Dade Medical Research Institute
  • Vista Health Research
  • Advanced Research Institute
  • Meridien Research
  • Physician Care Clinical Research
  • Advance Clinical Research
  • Northwestern Memorial Hospital
  • Southern Illinois University
  • The Iowa Clinic
  • Cypress Medical Research Center
  • Southern Clinical Research Associates
  • Omni Fertility Clinical Research LLC
  • Johns Hopkins Outpatient Center
  • OB/Gyn Associates
  • Onyx Clinical Research
  • Valley OB/GYN Clinic, PC
  • Mayo Clinic
  • Montefiore Medical Center
  • SUNY Downstate Medical Center
  • OB•GYN Associates of WNY
  • PMG Research of Charlotte
  • Carolina's Women's Research and Wellness Center
  • Rapha Institute For Clinical Research
  • Lyndhurst Clinical Research
  • Unified Women's Clinical Research d/b/a Lyndhurst Clinical Research
  • Main Line Fertility Center
  • Penn State Health - Milton S. Hershey Medical Center
  • Clinical Trials of South Carolina
  • Austin Area Ob, Gyn and Fertility
  • Corpus Christi Women's Clinic
  • Advances in Health, Inc.
  • Center of Reproductive Medicine LLC
  • Wasatch Clinical Research
  • Tidewater Clinical Research, Inc.
  • OB/GYN Specialists of Richmond

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Quinagolide 360 µg

Quinagolide 720 µg

Quinagolide 1080 µg

Placebo

Arm Description

Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg

Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg

Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg

Vaginal ring containing matching placebo

Outcomes

Primary Outcome Measures

Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes from baseline to cycle 4.

Secondary Outcome Measures

Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Days with menstrual bleeding (dysmenorrhea). No menstrual bleeding (non-menstrual pelvic pain) Changes from baseline to cycle 4
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles.
Frequency of Avoiding Sexual Intercourse Due to Expected Pain
The participants recorded daily if they had sexual intercourse, in an e-diary. For the days when participants did not have intercourse, the participant recorded if the reason for not having intercourse was because they expected pain: "Yes" (I did not have intercourse this day, because I expected pain) or "No" (I did not have intercourse this day, but this was not because I expected pain). The numbers represent the cumulative number of days with no intercourse, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles.
Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain.
Assessed weekly by participants in an e-Diary. EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. Changes over 4 menstrual cycles.
Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period
The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded if this was menstrual bleeding: "Yes" (I had a vaginal bleeding that was menstrual bleeding) or "No" (I had a vaginal bleeding that was not menstrual bleeding). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
Changes in Vaginal Bleeding Pattern.
The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded the assessed bleeding volume as either spotting (tiny amount of blood on underwear or panty liners), light bleeding (requiring 1-3 sanitary pads or tampons per day), moderate bleeding (requiring 4-6 sanitary pads or tampons per day), or heavy bleeding (requiring more than 6 sanitary pads or tampons per day). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Assessed daily by participants in an e-Diary
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Assessed daily by participants in an e-Diary
Responder Rate
Assessed as ≥30%, ≥50% and ≥70% reduction from the baseline in mean daily NRS score for the worst endometriosis-related pain, dysmenorrhea and non-menstrual pelvic pain and for the worst endometriosis-related pain impact
Changes in the Mean Individual and Total Symptom and Sign Severity Scores
Assessed by the Biberoglu and Behrman (B&B) scale which is a 4-point scale with 0=none and 3=severe. The scores are the mean individual scores. The B&B scale consists of two parts. The first part of the B&B scale evaluates symptoms of endometriosis (i.e. pain). There are 3 subscales: pelvic pain(A, 0=none and 3=severe), dysmenorrhea (B, 0=none and 3=severe), and dyspareunia(C, 0=none and 3=severe). The total pelvic pain score is the sum of the three scores, i.e. A+B+C, which can range from 0 to 9. The second part of the B&B scale evaluates signs of endometriosis. There are 2 subscales pelvic tenderness (D, 0=none and 3=severe) and induration (E, 0=none and 3=severe) based on findings from a pelvic examination. The total physical pain score is the sum of the two scores, i.e. D+E, which can range from 0 to 6. The total symptom and sign severity score is the sum of all five scores, i.e. A+B+C+D+E, which can range from 0 to 15. The values are the change from baseline to cycle 4.
Changes in the Endometriosis Health Profile-30 (EHP-30) Scores
Assessed by the EHP-30 quality-of-life questionnaire completed by participants. Score ranges from 0-100 with lower score denoting improvement.
Changes in Patient Global Impression of Severity (PGIS) Scores
Assessed by the PGIS scale completed by participants. PGIS is a 6-point scale depicting a participant's rating of their current conditions from "good" to "bad". It ranges from 0 (none) to 5 (very severe).
Patient Global Impression of Change (PGIC) Scores
Assessed by the PGIC scale completed by participants. PGIC is a 7-point scale depicting a patient's rating of their overall improvement from "good" to "bad".
Plasma Concentration of Quinagolide and Metabolites
Assessed by blood samples collection
Serum Levels of Mid-luteal Phase Progesterone
Assessed by blood samples collection
Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml)
Assessed by blood samples collection
Serum Levels of Estradiol
Assessed by blood samples collection
Serum Levels of Prolactin
Assessed by blood samples collection
Serum Levels of Thyrotropin (TSH)
Assessed by blood samples collection
Serum Levels of Insulin-like Growth Factor-1 (IGF-1)
Assessed by blood samples collection
Changes in Bone Turnover Markers, Determined by Bone Resorption Marker Serum C-terminal Crosslinking Telopeptide of Type 1 Collagen (s-CTx)
Assessed by blood samples collection. Changes from baseline to cycle 4
Changes in Bone Turnover Markers, Determined by Bone Formation Marker Serum Procollagen Type I N Propeptide (s-PINP)
Assessed by blood samples collection. Changes from baseline to cycle 4
Changes in ECG Parameters Including PR Interval at Cycle 4
Assessed by 12-lead ECG
Changes in ECG Parameters Including QRS Duration at Cycle 4
Assessed by 12-lead ECG
Changes in ECG Parameters Including QT Interval at Cycle 4
Assessed by 12-lead ECG
Changes in ECG Parameters Including QTcF Interval at Cycle 4
Assessed by 12-lead ECG
Proportion of Subjects With Abnormal Clinically Significant Echocardiography Findings Indicating Valvular Heart Disease
Assessed by echocardiography. Each echocardiography was to be assessed as normal or abnormal according to American College of Cardiology/American Heart Association guidelines for valvular heart disease. If abnormal, the level of valvular regurgitation and valvular stenosis was specified as mild, moderate or severe and valvular structure was evaluated as well. Measured at cycle 4.
Proportion of Subjects Identified With Potential Impulse Control Disorders
Assessed by the questionnaire for impulsive-compulsive disorders completed by participants. Measured at cycle 4.
Frequency and Intensity of Adverse Events
Assessed by an Adverse Events Log completed by the Investigator
Changes in Circulating Levels of Clinical Chemistry Parameters: Albumin
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Alkaline Phosphatase
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Alanine Aminotransferase
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Aspartate Aminotransferase
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Bicarbonate
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Direct Bilirubin
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Bilirubin
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Calcium
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Cholesterol
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Chloride
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Creatinine
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Gamma Glutamyl Transferase
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Glucose
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Potassium
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Lactate Dehydrogenase
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Phosphate
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Protein
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Sodium
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Urate
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Chemistry Parameters: Urea Nitrogen
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Basophils Absolute
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Basophils
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils Absolute
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Hematocrit
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Hemoglobin
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes Absolute
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Hemoglobin
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular HGB Concentration
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Volume
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes Absolute
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils Absolute
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Platelets
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Erythrocytes
Assessed by blood samples collection
Changes in Circulating Levels of Clinical Haematology Parameters: Leukocytes
Assessed by blood samples collection
Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity)
Assessed by urine sample collection (dip-stick test). Overall Urinalysis Result.
Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Chemistry Parameters
Assessed by blood samples collection
Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Haematology Parameters
Assessed by blood samples collection
Proportion of Subjects With Markedly Abnormal Changes in Urinalysis Parameters
Assessed by urine samples collection
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Assessed by a questionnaire completed by participants, addressing ring insertion
Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring
Assessed by a questionnaire completed by participants, addressing ring removal.
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Assessed by a questionnaire completed by participants, addressing any feeling of the ring while the ring is in the body.

Full Information

First Posted
September 14, 2018
Last Updated
August 16, 2023
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03692403
Brief Title
Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain
Acronym
RAQUEL
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial Assessing the Efficacy, Safety and Dose-response of Quinagolide Extended-release Vaginal Rings Administered Sequentially for 4 Menstrual Cycles in Women With Moderate to Severe Endometriosis-related Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 26, 2018 (Actual)
Primary Completion Date
February 14, 2022 (Actual)
Study Completion Date
February 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the efficacy of three doses of quinagolide administered as an extended-release vaginal ring compared to placebo on reduction of moderate to severe endometriosis-related pain

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis-related Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quinagolide 360 µg
Arm Type
Experimental
Arm Description
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Arm Title
Quinagolide 720 µg
Arm Type
Experimental
Arm Description
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Arm Title
Quinagolide 1080 µg
Arm Type
Experimental
Arm Description
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vaginal ring containing matching placebo
Intervention Type
Drug
Intervention Name(s)
Quinagolide 360 µg
Other Intervention Name(s)
FE 999051
Intervention Description
Vaginal ring containing quinagolide 360 µg for daily releases
Intervention Type
Drug
Intervention Name(s)
Quinagolide 720 µg
Other Intervention Name(s)
FE 999051
Intervention Description
Vaginal ring containing quinagolide 720 µg for daily releases
Intervention Type
Drug
Intervention Name(s)
Quinagolide 1080 µg
Other Intervention Name(s)
FE 999051
Intervention Description
Vaginal ring containing quinagolide 1080 µg for daily releases
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.
Description
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes from baseline to cycle 4.
Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Secondary Outcome Measure Information:
Title
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding
Description
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Days with menstrual bleeding (dysmenorrhea). No menstrual bleeding (non-menstrual pelvic pain) Changes from baseline to cycle 4
Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.
Description
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea.
Description
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain.
Description
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse.
Description
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles.
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Frequency of Avoiding Sexual Intercourse Due to Expected Pain
Description
The participants recorded daily if they had sexual intercourse, in an e-diary. For the days when participants did not have intercourse, the participant recorded if the reason for not having intercourse was because they expected pain: "Yes" (I did not have intercourse this day, because I expected pain) or "No" (I did not have intercourse this day, but this was not because I expected pain). The numbers represent the cumulative number of days with no intercourse, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function.
Description
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles.
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain.
Description
Assessed weekly by participants in an e-Diary. EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. Changes over 4 menstrual cycles.
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period
Description
The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded if this was menstrual bleeding: "Yes" (I had a vaginal bleeding that was menstrual bleeding) or "No" (I had a vaginal bleeding that was not menstrual bleeding). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in Vaginal Bleeding Pattern.
Description
The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded the assessed bleeding volume as either spotting (tiny amount of blood on underwear or panty liners), light bleeding (requiring 1-3 sanitary pads or tampons per day), moderate bleeding (requiring 4-6 sanitary pads or tampons per day), or heavy bleeding (requiring more than 6 sanitary pads or tampons per day). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Description
Assessed daily by participants in an e-Diary
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Description
Assessed daily by participants in an e-Diary
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Responder Rate
Description
Assessed as ≥30%, ≥50% and ≥70% reduction from the baseline in mean daily NRS score for the worst endometriosis-related pain, dysmenorrhea and non-menstrual pelvic pain and for the worst endometriosis-related pain impact
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in the Mean Individual and Total Symptom and Sign Severity Scores
Description
Assessed by the Biberoglu and Behrman (B&B) scale which is a 4-point scale with 0=none and 3=severe. The scores are the mean individual scores. The B&B scale consists of two parts. The first part of the B&B scale evaluates symptoms of endometriosis (i.e. pain). There are 3 subscales: pelvic pain(A, 0=none and 3=severe), dysmenorrhea (B, 0=none and 3=severe), and dyspareunia(C, 0=none and 3=severe). The total pelvic pain score is the sum of the three scores, i.e. A+B+C, which can range from 0 to 9. The second part of the B&B scale evaluates signs of endometriosis. There are 2 subscales pelvic tenderness (D, 0=none and 3=severe) and induration (E, 0=none and 3=severe) based on findings from a pelvic examination. The total physical pain score is the sum of the two scores, i.e. D+E, which can range from 0 to 6. The total symptom and sign severity score is the sum of all five scores, i.e. A+B+C+D+E, which can range from 0 to 15. The values are the change from baseline to cycle 4.
Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in the Endometriosis Health Profile-30 (EHP-30) Scores
Description
Assessed by the EHP-30 quality-of-life questionnaire completed by participants. Score ranges from 0-100 with lower score denoting improvement.
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in Patient Global Impression of Severity (PGIS) Scores
Description
Assessed by the PGIS scale completed by participants. PGIS is a 6-point scale depicting a participant's rating of their current conditions from "good" to "bad". It ranges from 0 (none) to 5 (very severe).
Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Patient Global Impression of Change (PGIC) Scores
Description
Assessed by the PGIC scale completed by participants. PGIC is a 7-point scale depicting a patient's rating of their overall improvement from "good" to "bad".
Time Frame
At cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Plasma Concentration of Quinagolide and Metabolites
Description
Assessed by blood samples collection
Time Frame
Within 5 days after first ring insertion and at around 1 month, 3 months, 3.5 months and 4 months after baseline (each cycle is approximately 28 days)
Title
Serum Levels of Mid-luteal Phase Progesterone
Description
Assessed by blood samples collection
Time Frame
At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Title
Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml)
Description
Assessed by blood samples collection
Time Frame
At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Title
Serum Levels of Estradiol
Description
Assessed by blood samples collection
Time Frame
At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Title
Serum Levels of Prolactin
Description
Assessed by blood samples collection
Time Frame
At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Title
Serum Levels of Thyrotropin (TSH)
Description
Assessed by blood samples collection
Time Frame
At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Title
Serum Levels of Insulin-like Growth Factor-1 (IGF-1)
Description
Assessed by blood samples collection
Time Frame
At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Title
Changes in Bone Turnover Markers, Determined by Bone Resorption Marker Serum C-terminal Crosslinking Telopeptide of Type 1 Collagen (s-CTx)
Description
Assessed by blood samples collection. Changes from baseline to cycle 4
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in Bone Turnover Markers, Determined by Bone Formation Marker Serum Procollagen Type I N Propeptide (s-PINP)
Description
Assessed by blood samples collection. Changes from baseline to cycle 4
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in ECG Parameters Including PR Interval at Cycle 4
Description
Assessed by 12-lead ECG
Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in ECG Parameters Including QRS Duration at Cycle 4
Description
Assessed by 12-lead ECG
Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in ECG Parameters Including QT Interval at Cycle 4
Description
Assessed by 12-lead ECG
Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in ECG Parameters Including QTcF Interval at Cycle 4
Description
Assessed by 12-lead ECG
Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Proportion of Subjects With Abnormal Clinically Significant Echocardiography Findings Indicating Valvular Heart Disease
Description
Assessed by echocardiography. Each echocardiography was to be assessed as normal or abnormal according to American College of Cardiology/American Heart Association guidelines for valvular heart disease. If abnormal, the level of valvular regurgitation and valvular stenosis was specified as mild, moderate or severe and valvular structure was evaluated as well. Measured at cycle 4.
Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Proportion of Subjects Identified With Potential Impulse Control Disorders
Description
Assessed by the questionnaire for impulsive-compulsive disorders completed by participants. Measured at cycle 4.
Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Frequency and Intensity of Adverse Events
Description
Assessed by an Adverse Events Log completed by the Investigator
Time Frame
From signing informed consent through study completion, around 8 months
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Albumin
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Alkaline Phosphatase
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Alanine Aminotransferase
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Aspartate Aminotransferase
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Bicarbonate
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Direct Bilirubin
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Bilirubin
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Calcium
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Cholesterol
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Chloride
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Creatinine
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Gamma Glutamyl Transferase
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Glucose
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Potassium
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Lactate Dehydrogenase
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Phosphate
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Protein
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Sodium
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Urate
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Chemistry Parameters: Urea Nitrogen
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Basophils Absolute
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Basophils
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils Absolute
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Hematocrit
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Hemoglobin
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes Absolute
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Hemoglobin
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular HGB Concentration
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Volume
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes Absolute
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils Absolute
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Platelets
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Erythrocytes
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Changes in Circulating Levels of Clinical Haematology Parameters: Leukocytes
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity)
Description
Assessed by urine sample collection (dip-stick test). Overall Urinalysis Result.
Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Chemistry Parameters
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Haematology Parameters
Description
Assessed by blood samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Title
Proportion of Subjects With Markedly Abnormal Changes in Urinalysis Parameters
Description
Assessed by urine samples collection
Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Description
Assessed by a questionnaire completed by participants, addressing ring insertion
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring
Description
Assessed by a questionnaire completed by participants, addressing ring removal.
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Description
Assessed by a questionnaire completed by participants, addressing any feeling of the ring while the ring is in the body.
Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pre-menopausal females aged ≥18 years at time of signing informed consent(s) with regular menstrual cycles. Body mass index (BMI) of 18-42 kg/m2 (both inclusive) at screening. Initial confirmation of endometriosis by laparoscopy or laparotomy within the last 10 years before the run-in visit or visualization of persistent endometrioma by repeat ultrasound. Transvaginal ultrasound documenting a uterus with no clinically significant abnormalities and presence of at least one ovary with no clinically significant abnormalities (with the exception of endometrioma) at the run-in visit. Eligible participants experienced moderate to severe endometriosis-related pain, which was defined as at the run-in visit, the participant having an NRS score of ≥5 for the worst endometriosis related pain during the past menstrual cycle and at randomization, the participant having a mean daily NRS score of ≥4 for the worst endometriosis related pain during each run-in menstrual cycle. Exclusion Criteria: History of no relief of endometriosis related pain after any medical therapy or surgery. However, history of partial pain relief, discontinuation due to side effects are not exclusionary. Known bone diseases (e.g. osteoporosis, Paget's disease and osteomalacia) affecting bone resorption or bone formation markers. Any significant abnormal findings of heart examinations before randomization. History of mental illness including occurrence of acute psychosis, bipolar disorders and schizophrenia (except for well-controlled anxiety and/or depression with no changes to interventions for 6 months prior to start of run-in) History of impulse control disorders including pathological gambling, compulsive buying, hypersexuality, and binge eating or being identified with potential impulse control disorder by the questionnaire for impulsive-compulsive disorders (a score ≥2 for any sub-questions of Question 3 or a score ≥1 for any sub-questions of Question 4) prior to randomization. History of orthostatic hypotension or recurrent syncope.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Compliance
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Marchand Institute for Minimally Invasive Surgery
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85209
Country
United States
Facility Name
Arkansas Primary Care Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
UConn Health Lowell P Weicker Jr Clinical Research Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Yale Fertility Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Omega Research Consultants
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
South Florida Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Florida Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Miami Dade Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Vista Health Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Advanced Research Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Physician Care Clinical Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Advance Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83643
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Southern Illinois University
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9664
Country
United States
Facility Name
The Iowa Clinic
City
Ankeny
State/Province
Iowa
ZIP/Postal Code
50023
Country
United States
Facility Name
Cypress Medical Research Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Southern Clinical Research Associates
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Omni Fertility Clinical Research LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71118
Country
United States
Facility Name
Johns Hopkins Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
OB/Gyn Associates
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Onyx Clinical Research
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Valley OB/GYN Clinic, PC
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
OB•GYN Associates of WNY
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
PMG Research of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Carolina's Women's Research and Wellness Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Rapha Institute For Clinical Research
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28314
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Unified Women's Clinical Research d/b/a Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Main Line Fertility Center
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Penn State Health - Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Clinical Trials of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Austin Area Ob, Gyn and Fertility
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Corpus Christi Women's Clinic
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
Advances in Health, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Center of Reproductive Medicine LLC
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Tidewater Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
OB/GYN Specialists of Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain

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