Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Quinagolide

Criteria

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 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.

• 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.