At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 802 enrolled

Drug / intervention

Relugolix +1 moredrug

Likely dose

Estradiol/norethindrone acetate 1.0 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/NCT03654274

NCT03654274Phase 3Completed

Compare CT.gov

SPIRIT EXTENSION: An International Phase 3 Open-Label, Single-Arm, Safety and Efficacy Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Endometriosis-Associated Pain

Myovant Sciences GmbH·interventional·Posted Aug 31, 2018·Updated Aug 8, 2023

In Brief

A Phase 3 clinical trial evaluating Relugolix and Estradiol/norethindrone acetate for Endometriosis. Completed, enrolled 802 participants across 169 sites in 20 countries.

Detailed Summary

The purpose of this study is to evaluate the long-term efficacy and safety of relugolix 40 milligram (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) for up to 104 weeks on endometriosis-associated pain in participants who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT-601-3102).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsEndometriosis

CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, Finland, Georgia, Hungary, Italy, New Zealand, Poland, Portugal, Romania, South Africa, Spain, Ukraine, United States

Collaborators--

Timeline

Phase 3CompletedFinished

20192020202120222023202420252026

Enrollment StartMay 2018

First PostedAug 2018

Primary CompletionDec 2021

Study CompletionJan 2023

TodayJul 2026

First PostedAug 31, 2018

Enrollment StartMay 22, 2018

Primary CompletionDec 16, 2021

Study CompletionJan 31, 2023

TodayJul 2, 2026

Enrollment to primary: 3.6 yearsPosted 7.8 years ago

Interventions

Relugolixdrug

Relugolix 40-mg tablet administered orally once daily

Estradiol/norethindrone acetatedrug

Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily