RecruitingPhase 3

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

United States1,000 participantsStarted 2023-08-14

Plain-language summary

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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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Exclusion criteria

✕. For patients entering de novo a Z-score ≤ -1.5 or T-score ≤ -2.0 (if ≥ 40 years of age)
✕. For patients entering from MVT-601-050 (NCT04756037; SERENE) a 12-month on-treatment DXA demonstrating Z-score ≤ -2.0, T-score ≤ -2.5 (if ≥ 40 years of age), or BMD loss ≥ 8% compared with pre-treatment baseline;

What they're measuring

Percent change from baseline in BMD (bone mineral density) at Month 48 on-treatment at lumbar spine (L1-L4) in women with uterine fibroids.

Timeframe: Baseline up to Month 48

Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in women with endometriosis.

Timeframe: Baseline up to Month 48

Trial details

NCT IDNCT05862272

SponsorSumitomo Pharma Switzerland GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-07

Contact for this trial

Clinical Trials at Myovant

650-278-8743 ClinicalTrials@Myovant.com

View on ClinicalTrials.gov More Uterine Fibroids trials