Elagolix in Works to Manage Uterine Fibroid-Associated Bleeding

Elagolix, currently submitted to the FDA as a treatment for endometriosis-associated pain, is being studied in 2 trials for the management of sex hormone-mediated diseases like uterine fibroids.

An ongoing phase 3 study of potential sex hormone-mediated disease treatment elagolix, is testing its capability in combination with estradiol/norethindrone acetate (Activella) for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Elagolix, currently under submission with the US Food and Drug Administration (FDA) to treat conditions like uterine fibroids, will have its efficacy, safety and tolerability tested both alone and with Activella.

The study (M12-815) is measuring the percentage of responders based on menstrual blood loss (MBL) volume reduction through 6 months — the final month of treatment period — assessed using alkaline hematin methodology.

The study focuses on premenopausal females 18—51 years old with a diagnosis of uterine fibroids documented by a pelvic transvaginal and transabdominal ultrasound (TAU, TVU).

Subjects have heavy menstrual bleeding (HMB) associated with uterine fibroids as evidenced by an MBL greater than 80 mL during each of the 2 screening menses measured by the alkaline hematin method. They also have an adequate endometrial biopsy performed during screening showing no clinically significant endometrial pathology.

Secondary outcomes include a change in MBL volume from the baseline to the last 28 days of treatment; a monthly change in MBL volume from baseline to month 6; a percentage of subjects with suppression of bleeding during the 6-month treatment period; and a percent of subjects with increase in hemoglobin through month 6.

The final data collection for the primary outcome measure is estimated for May 2018.

Study M12-817, a replica of study M12-815, estimated its final data collection date as July 2018.

An extension study of the trials, M12-816, is enrolling participants by invitation only. The study focuses on women who already received 6 months of treatment in the phase 3 clinical trials.

The main outcome is to evaluate the long-term efficacy and safety of elagolix administered alone and in combination with Activella for an additional 6 months in the treatment of heavy menstrual bleeding associated with uterine fibroids.

The primary outcome is to measure the percentage of responders based on MBL volume reduction from baseline to the final month of treatment period through 12 months. The secondary outcomes were similar to the 2 initial studies, with the addition of suppression of bleeding — defined as having no days of bleeding — spotting is allowed — during a 28-day interval.

Participants included in the study are to have completed the 6-month treatment period of their respective pivotal study and not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at month 6 of the treatment period.

Participant’s endometrial biopsy from the month 6 visit should also show no clinically significant endometrial pathology.

The follow-up study is to last 18 months and consist of 2 periods — a 6-month treatment period and a post-treatment follow-up period for 12 months.

The estimated primary completion date of the study extension is January 2019.

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