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SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

NCT03204318 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 638

Last updated 2021-06-28

No results posted yet for this study

Summary

The purpose of this study is to determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.

Conditions

  • Endometriosis Related Pain

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)/NETA (0.5 mg) administered orally once daily.

DRUG

Estradiol/norethindrone acetate placebo

E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor.

DRUG

Relugolix placebo

Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.

Sponsors & Collaborators

  • Myovant Sciences GmbH

    lead INDUSTRY

Principal Investigators

  • Myovant Medical Monitor · Myovant Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-12-07
Primary Completion
2020-06-09
Completion
2021-04-08
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Finland
  • Hungary
  • Poland
  • Portugal
  • 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 NCT03204318 on ClinicalTrials.gov