Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain
NCT ID: NCT03692403
Last Updated: 2023-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2018-12-26
2022-02-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Quinagolide 360 µg
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg
Vaginal ring containing quinagolide 360 µg for daily releases
Quinagolide 720 µg
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg
Vaginal ring containing quinagolide 720 µg for daily releases
Quinagolide 1080 µg
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg
Vaginal ring containing quinagolide 1080 µg for daily releases
Placebo
Vaginal ring containing matching placebo
Placebo
Matching placebo
Interventions
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Quinagolide 360 µg
Vaginal ring containing quinagolide 360 µg for daily releases
Quinagolide 720 µg
Vaginal ring containing quinagolide 720 µg for daily releases
Quinagolide 1080 µg
Vaginal ring containing quinagolide 1080 µg for daily releases
Placebo
Matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Marchand Institute for Minimally Invasive Surgery
Mesa, Arizona, United States
Arkansas Primary Care Clinic
Little Rock, Arkansas, United States
Medical Center for Clinical Research
San Diego, California, United States
UConn Health Lowell P Weicker Jr Clinical Research Center
Farmington, Connecticut, United States
Yale Fertility Center
New Haven, Connecticut, United States
Omega Research Consultants
DeBary, Florida, United States
South Florida Research Center
Miami, Florida, United States
Florida Research Center
Miami, Florida, United States
Miami Dade Medical Research Institute
Miami, Florida, United States
Vista Health Research
Miami, Florida, United States
Advanced Research Institute
New Port Richey, Florida, United States
Physician Care Clinical Research
Sarasota, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Advance Clinical Research
Meridian, Idaho, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
The Iowa Clinic
Ankeny, Iowa, United States
Cypress Medical Research Center
Wichita, Kansas, United States
Southern Clinical Research Associates
Metairie, Louisiana, United States
Omni Fertility Clinical Research LLC
Shreveport, Louisiana, United States
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States
OB/Gyn Associates
Silver Spring, Maryland, United States
Onyx Clinical Research
Flint, Michigan, United States
Valley OB/GYN Clinic, PC
Saginaw, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
OB•GYN Associates of WNY
West Seneca, New York, United States
PMG Research of Charlotte
Charlotte, North Carolina, United States
Carolina's Women's Research and Wellness Center
Durham, North Carolina, United States
Rapha Institute For Clinical Research
Fayetteville, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Unified Women's Clinical Research d/b/a Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Main Line Fertility Center
Bryn Mawr, Pennsylvania, United States
Penn State Health - Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Austin Area Ob, Gyn and Fertility
Austin, Texas, United States
Corpus Christi Women's Clinic
Corpus Christi, Texas, United States
Advances in Health, Inc.
Houston, Texas, United States
Center of Reproductive Medicine LLC
Webster, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Tidewater Clinical Research, Inc.
Norfolk, Virginia, United States
OB/GYN Specialists of Richmond
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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000165
Identifier Type: -
Identifier Source: org_study_id
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