Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT06671548
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Relugolix — DRUG
    * Relugolix (40 mg) tablet administered orally once daily； * megestrol acetate (1 mg) administered orally once daily； * medroxyprogesterone acetate (2 mg) administered orally once daily
  • Relugolix placebo — DRUG
    Relugolix (0 mg) tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor. megestrol acetate (0 mg) administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor. medroxyprogesterone acetate (0 mg) administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.

Study Details

The goal of this clinical trial is to determine the benefit of relugolix 40 milligrams (mg) once a day compared with placebo in heavy menstrual bleeding associated with uterine fibroids. The main question\[s\] it aims to answer are: * the benefit of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids * the safety of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids

Key Dates

Start date
Jan 15, 2024
Status verified
Jan 2026
Primary completion
Nov 12, 2026
Completion
Jan 7, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Relugolix plus megestrol acetate/medroxyprogesterone acetate (the treatment group)
    Relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg for 12 weeks followed by 12 weeks of daily oral relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg..
  • Placebo Comparator: Placebo (the placebo group)
    Relugolix 40 mg placebo co-administered with megestrol acetate 1 mg placebo and medroxyprogesterone acetate 2 mg placebo for 12 weeks followed by 12 weeks of daily oral relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg.

Primary Outcome Measure

Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And ≥ 50% Reduction From Baseline MBL Volume [ Time Frame: From Baseline up to the last 35 days of the double-blind treatment period ]

Central Contacts

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