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SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
NCT03654274 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Relugolix
- DRUG Estradiol/norethindrone acetate
Study Locations (20)
Florida
- Aventura — Aventura
- Fort Myers — Fort Myers
- Hialeah — Hialeah
- Hialeah — Hialeah
- Margate — Margate
- Miami — Miami
- Miami — Miami
- Sarasota — Sarasota
- Tampa — Tampa
Arizona
- Scottsdale — Scottsdale
- Tucson — Tucson
- Tuscon — Tucson
California
- Canoga Park — Canoga Park
- Los Angeles — Los Angeles
- San Diego — San Diego
Georgia
- Atlanta — Atlanta
- Atlanta — Atlanta
Alabama
- Andalusia — Andalusia
Colorado
- Greenwood Village — Greenwood Village
District of Columbia
- Washington — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 802 participants |
| Start Date | 2018-05-22 |
| Est. Completion | 2023-01-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03654274
The ClinicalTrials.gov registry entry for NCT03654274 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 802 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Myovant Sciences, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Endometriosis appearing as the primary indexed condition, and to 2 interventions — of which Relugolix is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03654274 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03654274 about?
NCT03654274 is a clinical study titled "SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain". 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 t...
What is the current status of trial NCT03654274?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 802 participants. The study started on 2018-05-22. Estimated completion is 2023-01-31.
What conditions does trial NCT03654274 study?
This clinical trial studies the following conditions: Endometriosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03654274?
The interventions under investigation include: Relugolix (DRUG), Estradiol/norethindrone acetate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03654274?
This trial is sponsored by Myovant Sciences, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03654274 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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