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NCT05862272 · ClinicalTrials.gov registry record · Phase 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
A Phase 3 study of Endometriosis and Uterine Fibroids, sponsored by Sumitomo Pharma Switzerland.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,000
- Enrollment target
- 20
- Study locations
NCT05862272 is a Phase 3 study of Endometriosis and Uterine Fibroids that is actively recruiting participants, run by Sumitomo Pharma Switzerland. The registered enrollment target is 1,000 participants, above the 243-participant average among 48 other Endometriosis trials with a reported enrollment target (312% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT05862272, a Phase 3 study of Endometriosis and Uterine Fibroids, is actively recruiting participants, sponsored by Sumitomo Pharma Switzerland.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Relugolix Combination Tablet
Study Locations (20)
California
- Burbank - Burbank
- Canoga Park - Canoga Park
- Encinitas - Encinitas
- Inglewood - Inglewood
- Lomita - Lomita
- Long Beach - Long Beach
- Los Angeles - Los Angeles
- Sacramento - Sacramento
- San Fernando - San Fernando
- Stanford - Stanford
- Valley Village - Valley Village
Arizona
- Chandler - Chandler
- Mesa - Mesa
- Peoria - Peoria
- Phoenix - Phoenix
- Tucson - Tucson
Colorado
- Aurora - Aurora
- Greenwood Village - Greenwood Village
- Lakewood - Lakewood
Alabama
- Mobile - Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2023-08-14 |
| Est. Completion | 2030-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05862272
The ClinicalTrials.gov registry entry for NCT05862272 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 243-participant average among 48 other Endometriosis trials with a reported enrollment target (312% higher). The listed sponsor is Sumitomo Pharma Switzerland, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Endometriosis appearing as the primary indexed condition, and to 1 intervention - of which Relugolix Combination Tablet is the first listed.
NCT05862272 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT05862272 about?
NCT05862272 is a clinical study titled "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 leiomyoma...
What is the current status of trial NCT05862272?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2023-08-14. Estimated completion is 2030-09.
What conditions does trial NCT05862272 study?
This clinical trial studies the following conditions: Endometriosis, Uterine Fibroids.
What interventions are being tested in trial NCT05862272?
The interventions under investigation include: Relugolix Combination Tablet (DRUG).
Who is sponsoring clinical trial NCT05862272?
This trial is sponsored by Sumitomo Pharma Switzerland, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05862272 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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