Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain
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
- Endometriosis-related Pain
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Double (Participant, Investigator)
Quinagolide 360 µg
|Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg||
Quinagolide 720 µg
|Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg||
Quinagolide 1080 µg
|Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg||
|Vaginal ring containing matching placebo||
- Ferring Pharmaceuticals