Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Endometriosis-related Pain

In brief

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

Key facts

Study ID

NCT03692403

Run by

Ferring Pharmaceuticals

People needed

22

Starts

2018-12-26

Expected to finish

2022-02-14

Last updated by the study team

2023-08-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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