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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2026 to Nov 12, 2026 Completion date: Feb 2027 to Jan 7, 2027 · Start date: Feb 28, 2025 to Jan 15, 2024 · Secondary endpoints: details revised at 1 of 1 entry · 1 morev4 Show 4 more changesShow less
    • Completion date: Feb 2027 to Jan 7, 2027
    • Start date: Feb 28, 2025 to Jan 15, 2024
    • Secondary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2025 to Feb 28, 2025 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Jan 2025 to Feb 28, 2025
    • Site details revised
  3. Interventions: Relugolix placebo+megestrol acetate placebo+medroxyprogesterone acetate placebo (Drug), Relugolix+megestrol acetate+medroxyprogesterone… to Relugolix (Drug), Relugolix placebo (Drug)v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06671548
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Heavy Menstrual Bleeding, Uterine Fibroids
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov