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SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain

NCT03654274 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 802

Last updated 2023-08-08

Study results available
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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).

Conditions

  • Endometriosis

Interventions

DRUG

Relugolix

Relugolix 40-mg tablet administered orally once daily

DRUG

Estradiol/norethindrone acetate

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

Sponsors & Collaborators

  • Myovant Sciences GmbH

    lead INDUSTRY

Principal Investigators

  • Myovant Medical Monitor · Myovant Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-05-22
Primary Completion
2021-12-16
Completion
2023-01-31
FDA Drug
Yes

Countries

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

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 NCT03654274 on ClinicalTrials.gov