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).
  • 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.
  • Transvaginal ultrasound documenting a uterus with no clinically significant abnormalities and presence of at least one ovary with no clinically significant abnormalities (e.g. no evidence of endometrioma greater than 3 cm in diameter) at the run-in visit.
  • Having moderate to severe endometriosis-related pain.
  • Willing to use a non-hormonal barrier method (i.e. condom) for contraception from randomization to the end-of-trial. This is not required if adequate contraception is achieved by vasectomy of the sexual partner or surgical sterilisation of the subject.
  • Willing to avoid the use of vaginal douches or any other intravaginally administered medications or devices from randomization to the end of treatment.
  • Willing to change usual analgesics to rescue analgesics as permitted by protocol for endometriosis-related pain from the start of run-in to the end-of-trial.

Exclusion Criteria

  • Use of depot medroxyprogesterone acetate (MPA) within 10 months of the start of run-in.
  • Use of gonadotropin releasing hormone (GnRH) agonists (3 months depot) or dopamine agonists within 6 months of the start of run-in.
  • Use of GnRH agonists (1 month depot) or intrauterine device within 3 months of the start of run-in.
  • Use of GnRH antagonist, combined oral contraceptive pill or progestin-only pill within 1 month of the start of run-in.
  • Undiagnosed abnormal vaginal bleeding.
  • 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.

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

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10461

More Details

NCT ID
NCT03692403
Status
Recruiting
Sponsor
Ferring Pharmaceuticals

Study Contact

Global Clinical Compliance
+1 833-548-1402 (US/Canada)
DK0-Disclosure@ferring.com

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.