Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain
Condition: Endometriosis-related Pain
MeSH terms: Endometriosis
Intervention: Quinagolide 360 µg; Quinagolide 720 µg; Quinagolide 1080 µg; Placebo
Intervention description: Vaginal ring containing quinagolide 360 µg for daily releases; Vaginal ring containing quinagolide 720 µg for daily releases; Vaginal ring containing quinagolide 1080 µg for daily releases; Matching placebo
Intervention MeSH terms: Quinagolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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
    

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.