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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

NCT04756037 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1164

Last updated 2026-05-13

Study results available
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Summary

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

Conditions

  • Contraception

Interventions

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.

Sponsors & Collaborators

  • Sumitomo Pharma Switzerland GmbH

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-18
Primary Completion
2025-02-25
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04756037 on ClinicalTrials.gov