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NCT03654274 · ClinicalTrials.gov registry record · Phase 3
SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
A Phase 3 study of Endometriosis, sponsored by Myovant Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 802
- Enrollment target
- 20
- Study locations
NCT03654274 is a Phase 3 study of Endometriosis that has completed, run by Myovant Sciences. The registered enrollment target is 802 participants, above the 248-participant average among 48 other Endometriosis trials with a reported enrollment target (223% higher). The trial reports 20 study locations across 7 states.
The verdict
NCT03654274, a Phase 3 study of Endometriosis, has completed, sponsored by Myovant Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 802 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 802 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 248-participant average among 48 other Endometriosis trials with a reported enrollment target (223% higher). The listed sponsor is Myovant Sciences, which has 11 total studies on file at ClinicalTrials.gov.
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.
NCT03654274 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, Arizona, California.
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.
What interventions are being tested in trial NCT03654274?
The interventions under investigation include: Relugolix (DRUG), Estradiol/norethindrone acetate (DRUG).
Who is sponsoring clinical trial NCT03654274?
This trial is sponsored by Myovant Sciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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