Ensayos clínicos

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 sterilization 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.