Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Summary
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.
Timeline
- Start
- 2018-10-16
- Primary completion
- 2021-02-19
- Completion
- 2021-10-20
Outcome
Met primary endpoint
registry Relugolix Plus E2/NETA (Group A) vs Placebo (Group B); p <0.0001; Treatment difference 63.36 (95% CI 52.85 to 73.86) NCT03751124 ↗
paper Through week 76, 78.4% of women on relugolix combination therapy maintained menstrual blood loss volume <80 mL vs 15.1% in the placebo group PMID 37666383 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol/norethindrone acetate | Unknown | 0.5 mg | Oral |
| Subject | Estradiol/norethindrone acetate | Unknown | 1 mg | Oral |
| Subject | Relugolix | Small molecule | 40 mg | Oral |