A Phase 3B, Single-Arm, Open-Label Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids or Moderate to Severe Pain Associated With Endometriosis
Status: Recruiting
Location: See all (116) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:
• 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 of life. or
• 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.
• Has a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the allocation visit (or Month 12 if entering from MVT-601-050 \[NCT04756037; SERENE\]);
• In good physical and mental health based on medical, surgical, and gynecological history as well as physical, gynecological, and breast examinations, clinical laboratory test results, and vital sign measurements;
• Has a body mass index ≥ 18 kg/m\^2.
Locations
United States
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Seattle
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Contact Information
Primary
Clinical Trials at Myovant
ClinicalTrials@Myovant.com
650-278-8743
Time Frame
Start Date:2023-08-14
Estimated Completion Date:2030-09
Participants
Target number of participants:1000
Treatments
Experimental: Relugolix Combination Tablet
Participants will receive relugolix combination therapy orally once daily for 48 months.