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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

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

ArmDescriptionAssigned Intervention
Experimental
Quinagolide 360 µg 		Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
  • Drug: Quinagolide 360 µg
    Vaginal ring containing quinagolide 360 µg for daily releases
    Other names:
    • FE 999051
Experimental
Quinagolide 720 µg 		Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
  • Drug: Quinagolide 720 µg
    Vaginal ring containing quinagolide 720 µg for daily releases
    Other names:
    • FE 999051
Experimental
Quinagolide 1080 µg 		Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
  • Drug: Quinagolide 1080 µg
    Vaginal ring containing quinagolide 1080 µg for daily releases
    Other names:
    • FE 999051
Placebo Comparator
Placebo 		Vaginal ring containing matching placebo
  • Drug: Placebo
    Matching placebo

More Details

Status
Completed
Sponsor
Ferring Pharmaceuticals

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.