drugset / Trial / NCT05862272
A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-08-14
- Primary completion
- 2029-07
- Completion
- 2030-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 1 mg | Oral |
| Subject | Norethindrone | Unknown | 0.5 mg | Oral |
| Subject | Relugolix | Small molecule | 40 mg | Oral |