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

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 ID

NCT05862272

Phase

PHASE3

Sponsor

Sumitomo Pharma Switzerland GmbH

Status

RECRUITING

Cancer Type

Uterine Cancer

Interventions

Relugolix Combination Tablet

Locations (sample)

Mobile, Alabama, United States|30.69436,-88.04305
Chandler, Arizona, United States|33.30616,-111.84125
Mesa, Arizona, United States|33.42227,-111.82264
Peoria, Arizona, United States|33.5806,-112.23738
Phoenix, Arizona, United States|33.44838,-112.07404

Key Eligibility Criteria

Is a premenopausal woman, 18 to 50 years of age (inclusive);
A diagnosis of uterine fibroids confirmed by imaging or review of medical records and reports heavy menstrual bleeding negatively affecting quality…
A diagnosis of endometriosis that is associated with moderate to severe pain.;
If at risk of pregnancy is willing to avoid pregnancy for 4 years (the duration of the treatment period) using nonhormonal methods of contraception.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Uterine Cancer Trials on Trialify →