Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain
Purpose
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
Condition
- Endometriosis-related Pain
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Quinagolide 360 µg |
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg |
|
Experimental Quinagolide 720 µg |
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg |
|
Experimental Quinagolide 1080 µg |
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg |
|
Placebo Comparator Placebo |
Vaginal ring containing matching placebo |
|
More Details
- Status
- Completed
- Sponsor
- Ferring Pharmaceuticals