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A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 93 to 120v13
  2. Study sites: 92 to 93v12
  3. Study sites: 91 to 92v11
  4. Lead sponsor: Myovant Sciences GmbH to Sumitomo Pharma Switzerland GmbHv10
  5. Study sites: 80 to 91v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 71 to 80v8
  2. Study sites: 58 to 71v7
  3. Study sites: 39 to 58v6
  4. Start date: Sep 14, 2023 to Aug 14, 2023
    • Secondary endpoints: details revised at 2 of 15 entries
    v5
  5. Study sites: 26 to 39v4
  6. Trial status: Not Yet Recruiting to Recruitingv3 Show 6 more changesShow less
    • Start date changed from estimate of May 2023 to Sep 14, 2023
    • Study sites: 0 to 26
    • Primary completion date: May 2029 to Jul 2029
    • Study completion date: Aug 2030 to Sep 2030
    • Eligibility criteria expanded, about 77 words
    • Secondary endpoints: details revised at 2 of 15 entries
  7. Primary endpoints revised (2)v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or with moderate-to-severe pain associated with endometriosis.
Trial Details
NCT Number NCT05862272
Lead Sponsor Sumitomo Pharma Switzerland GmbH
Conditions
(from sponsor)		 Uterine Fibroids, Endometriosis
Related terms Endometriosis, Leiomyoma, Myofibroma
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov