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Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy — SERENE  

Contraception Clinical Trial

Official title:
A Phase 3, Single-Arm, Open-Label Study to Evaluate the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are 18 to 50 Years of Age and at Risk for Pregnancy

Clinical Trial Summary

The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.

Clinical Trial Description

This is a single-arm, open-label, phase 3 study to assess the contraceptive efficacy of relugolix combination therapy (relugolix 40 milligrams [mg], estradiol [E2] 1 mg, and norethindrone acetate [NETA] 0.5 mg). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04756037
Study type Interventional
Source Sumitomo Pharma Switzerland GmbH
Contact
Status Active, not recruiting
Phase Phase 3
Start date March 18, 2021
Completion date February 2026
View Details
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