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

Conditions

• Contraception

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Mar 18, 2021

Status verified

May 2026

Primary completion

Feb 25, 2025

Completion

Mar 31, 2026

Study Design

Enrollment

1,164 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Relugolix/E2/NETA
  Participants will receive relugolix combination therapy for 1 year (13 consecutive 28-day treatment cycles).

Primary Outcome Measure

Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the At-Risk Pearl Index (PI) [ Time Frame: 13 consecutive 28-day treatment cycles ]

Locations (109)

Related coverage on Hipa.ai

• Relugolix Combination Therapy Shows Contraceptive Efficacy in Phase 3 Trial
  Relugolix · May 13, 2026 · ClinicalTrials.gov
• Relugolix Combination Therapy Phase 3 Trial Reports 1.2% 1-Year Pregnancy Rate
  Relugolix · Feb 25, 2025 · ClinicalTrials.gov
• Relugolix Contraception Trial Completes Primary Phase on 2025-02-18
  Relugolix · Feb 18, 2025 · ClinicalTrials.gov

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