Last updated on December 2019

Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Endometriosis Related Pain
  • Age: Between 18 - 100 Years
  • Gender: Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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