Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain (NCT03692403) | Clinical Trial Compass
CompletedPhase 2
Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain
United States22 participantsStarted 2018-12-26
Plain-language 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
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, bipo…
What they're measuring
1
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.
Timeframe: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)