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

NCT03751124 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 229

Last updated 2024-06-25

Study results available
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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.

Conditions

  • Uterine Leiomyoma
  • Uterine Fibroids

Interventions

DRUG

Relugolix

Relugolix 40 mg tablet administered orally once daily

DRUG

Estradiol/norethindrone acetate

Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily

DRUG

Placebo for relugolix

Placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor

DRUG

Placebo for E2/NETA

Placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor

Sponsors & Collaborators

  • Myovant Sciences GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
51 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2021-02-19
Completion
2021-10-20
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Chile
  • Czechia
  • Hungary
  • Italy
  • Poland
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03751124 on ClinicalTrials.gov