Uterine Fibroids with Heavy Bleeding

This study is currently active

Northern California Research is conduction a study for uterine fibroids with heavy menstrual bleeding. Uterine fibroids (myoma) are harmless (benign), hormone-sensitive, smooth muscle tumors of the uterus. They are the most common tumor of the female reproductive tract in premenopausal women and are usually not noticeable. Uterine fibroids affect approximately 4 out of 10 women between the ages of 35 and 55. Fibroids can cause heavy menstrual bleeding, abdominal pressure, abdominal pain, increased urinary frequency, and infertility. Today, uterine fibroids are usually treated by surgery; however, depending on the extent of the surgery, this may cause infertility.

We are seeking FDA approval for a new medication to asses if it is safe and can reduce heavy menstrual bleeding associated with uterine fibroids in premenopausal women. The study is double-blind, meaning that neither you nor your study doctor/staff will know which study drug you will receive. You will be randomized into one out of 5 different study medication groups: You have an equal chance of being in any of the 5 study groups

In order to participate you must have a regular menstrual cycle, discontinue any hormonal birth control therapies and undergo an endometrial biopsy. You will be required to collect your used sanitary products and return to the site within the specific time period. The study sponsor will also provide all necessary sanitary items. All trial-related visits, tests, and medications will be provided to you at no cost. In addition, reimbursement for trial-related time and travel may be provided.

About the Study:

This phase 3b study seeks to evaluate the safety and efficacy of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study is double-blinded in the first year and an open-label in the second year.

Eligibility 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.

We partner with Camellia Women’s Health Comprehensive OB/GYN Services.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271489

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