NCT04756037

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,020 (estimated)
• Sponsor: Sumitomo Pharma Switzerland GmbH · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Relugolix Combination Therapy	Participants will receive orally 1 fixed-dose combination tablet (relugolix 40 mg/E2 1 mg/NETA 0.5 mg) once daily.

Timeline

• Start date: 2021-03-18
• Primary completion: 2025-02-18
• Completion: 2026-02-01
• First posted: 2021-02-16
• Last updated: 2026-01-08

Locations

112 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study