Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Completed · Phase 3 · Has a placebo group

Conditions studied: Uterine Leiomyoma, Uterine Fibroids

In brief

The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients with uterine fibroids who have completed a total of 52 weeks of treatment, including a 24-week treatment period in a parent study (study MVT-601-3001 or MVT-601-3002) and a 28-week treatment period in the open-label extension study (MVT-601-3003), and who meet the definition of responder, defined as a patient who demonstrates a menstrual blood loss of \< 80 mL and at least a 50% reduction from parent study baseline menstrual blood loss volume on the alkaline hematin analysis of the feminine products returned at Week 48 in the extension study.

Key facts

Study ID

NCT03751124

Run by

Myovant Sciences GmbH

People needed

229

Starts

2018-10-16

Expected to finish

2021-10-20

Last updated by the study team

2024-06-25

Who can join

Age: 18 and older, up to 51. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Completed the open-label extension study (MVT-601-3003).
• Is a responder: Has a menstrual blood loss of < 80 mL AND at least a 50% reduction from the parent study Baseline based on the results of the alkaline hematin testing performed on the feminine products returned at the Week 48 visit of the extension study.
• Is not expected to undergo gynecological surgery or ablation procedures for uterine fibroids within the study period

You may not qualify if…

• Has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the Parent study or extension study.
• Has a weight that exceeds the weight limit of the dual-energy x-ray absorptiometry (DXA) scanner
• Has developed any contraindication to treatment with estradiol or norethindrone acetate
• Is currently pregnant or lactating, or intends to become pregnant during the study period
• Met a withdrawal criterion in the open-label extension (OLE) study.

Where it is running

• Mesa — Mesa, Arizona, United States
• Tucson — Tucson, Arizona, United States
• Canoga Park — Canoga Park, California, United States
• Huntington Beach — Huntington Beach, California, United States
• La Mesa — La Mesa, California, United States
• Los Angeles — Los Angeles, California, United States
• Norwalk — Norwalk, California, United States
• San Diego — San Diego, California, United States
• Denver — Denver, Colorado, United States
• Lakewood — Lakewood, Colorado, United States
• Aventura — Aventura, Florida, United States
• Clearwater — Clearwater, Florida, United States
• Deland — DeLand, Florida, United States
• Ft. Lauderdale — Fort Lauderdale, Florida, United States
• Fort Myers — Fort Myers, Florida, United States
• Jacksonville — Jacksonville, Florida, United States
• Jupiter — Jupiter, Florida, United States
• Margate — Margate, Florida, United States
• Miami — Miami, Florida, United States
• Miami — Miami, Florida, United States
• Miami — Miami, Florida, United States
• Orlando — Orlando, Florida, United States
• Oviedo — Oviedo, Florida, United States
• Sarasota — Sarasota, Florida, United States
• Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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