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.
Montefiore Medical Center
Active not recruiting 1825 Eastchester Road, Bronx, NY, USA 10461
Active not recruiting Saint Petersburg, FL, USA 33709
The Iowa Clinic
Active not recruiting 1410 Southwest Tradition Drive, Ankeny, IA, USA 50023
Austin Area Ob Gyn and Fertility
Active not recruiting Austin, TX, USA 78758
Johns Hopkins Outpatient Center
Active not recruiting 601 North Caroline Street, Baltimore, MD, USA 21287
SUNY Downstate Medical Center
Active not recruiting 450 Clarkson Avenue, Brooklyn, NY, USA 11203
Main Line Fertility Center
Active not recruiting 825 Old Lancaster Road, Bryn Mawr, PA, USA 19010
Clinical Trials of South Carolina
Active not recruiting 2695 Elms Plantation Boulevard, Charleston, SC, USA 29406
PMG Research of Charlotte
Active not recruiting 1700 Abbey Place, Charlotte, NC, USA 28209
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.