drugset / Trial / NCT03343067
A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both elagolix alone and elagolix plus estradiol/norethindrone acetate (E2/NETA) over 24 months in the management of endometriosis with associated moderate to severe pain in premenopausal women.
Timeline
- Start
- 2017-12-27
- Primary completion
- 2018-10-23
- Completion
- 2018-10-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elagolix | Small molecule | 150 mg | — |
| Subject | Elagolix | Small molecule | 200 mg | — |
| Subject | Estradiol | Other / unclassified | 1 mg | — |
| Subject | Norethindrone | Unknown | 0.5 mg | — |