Uterine Fibroid Trial
NCT03271489 | Phase 3 | Interventional
Do Uterine Fibroids Impact Your Life?
You may be eligible to participate in a clinical trial for a new treatment
Do Uterine Fibroids Impact Your Life? You may be eligible to participate in a clinical trial for a new treatment
Details for the study
Treatments and/or Procedures
Inclusion Criteria: - Participant is a premenopausal female at the time of Screening. - Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound [Transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)]. - Participant has Heavy Menstrual Bleeding (HMB) associated with uterine fibroids as evidenced by Menstrual Blood Loss (MBL) > 80 mL during each of two screening menses as measured by the alkaline hematin method. - Participant has negative urine and/or serum pregnancy test in Washout (if applicable) and/or Screening and just prior to first dose. - Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology. Exclusion Criteria: - Participant has screening pelvic ultrasound or Saline Infusion Sonohysterography (SIS) results that show a clinically significant gynecological disorder. - Participant has history of osteoporosis or other metabolic bone disease. - Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis. - Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder). - Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed.