CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,164 enrolled
Drug / intervention
Relugolix Combination Therapydrug
Likely dose
Relugolix Combination Therapy 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04756037
NCT04756037Phase 3Completed
CompareCT.gov

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

Sumitomo Pharma Switzerland GmbH·interventional·Posted Feb 16, 2021·Updated May 13, 2026

In Brief

A Phase 3 clinical trial evaluating Relugolix Combination Therapy for Contraception. Completed, enrolled 1,164 participants across 112 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedFeb 16, 2021
Enrollment StartMar 18, 2021
Primary CompletionFeb 25, 2025
Study CompletionMar 31, 2026
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 5.4 years ago

Interventions

Relugolix Combination Therapydrug

Participants will receive orally 1 fixed-dose combination tablet (relugolix 40 mg/E2 1 mg/NETA 0.5 mg) once daily.