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

Conditions

• Uterine Fibroids
• Uterine Leiomyoma

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 51 Years

Healthy Volunteers

Not accepted

Interventions

• Relugolix — DRUG
  Relugolix 40 mg tablet administered orally once daily
• Estradiol/norethindrone acetate — DRUG
  Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily
• Placebo for relugolix — DRUG
  Placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor
• Placebo for E2/NETA — DRUG
  Placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor

Study Details

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 Dates

Start date

Oct 16, 2018

Status verified

May 2024

Primary completion

Feb 19, 2021

Completion

Oct 20, 2021

Study Design

Enrollment

229 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Relugolix plus E2/NETA
  Relugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 52 weeks.
• Placebo Comparator: Placebo tablets and capsules
  * Placebo for relugolix co-administered with placebo for E2/NETA for up to 52 weeks or until heavy menstrual bleeding returns. * Retreatment with open-label relugolix with E2/NETA will be offered if heavy menstrual bleeding returns.

Primary Outcome Measure

Percentage Of Participants Who Maintained MBL Volume Of <80 Milliliters (mL) At Week 76 During The Randomized Treatment Period [ Time Frame: Week 52/Baseline up to Week 76 ]

Locations (72)

Find similar trials in Birmingham, AL

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