Endometriosis-related Pain Clinical Trial
Have you or your loved ones been diagnosed with endometriosis-related pain?
You may be eligible to participate in a endometriosis-related pain clinical trial.
Have you or your loved ones been diagnosed with endometriosis-related pain? You may be eligible to participate in a endometriosis-related pain clinical trial.
Details for the study
Treatments and/or Procedures
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.