Premenopausal Endometriosis Treatment Study
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
- Sex at Birth: Female
- Age: Adult (18 - 64)
- Accepting Healthy People: No
- Type: Observational
- Trial Phase: Phase III
- Conditions Being Studied:
Study Purpose
The purpose of this research study is to characterize changes in bone mineral density during continuous treatment with the investigational medication for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with moderate-to-severe pain associated with endometriosis.
Who Can Participate
Premenopausal women aged 18 – 50 years, who have a diagnosis of moderate to severe pain associated with endometriosis may be eligible to participate.
Locations
UH Landerbrook Health Center
5850 Landerbrook Drive
Mayfield Heights OH, 44124
UH Ahuja Medical Center
3999 Richmond Road
Beachwood OH, 44122
- UH IRB: SITE00002089
- StudyID: 2023-01319
- ClinicalTrials.gov: NCT05862272
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