SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
Public ClinicalTrials.gov record NCT03654274. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03654274
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 802 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 51 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 22, 2018 (Actual)
- Primary completion
- Dec 16, 2021 (Actual)
- Completion
- Jan 31, 2023 (Actual)
- Last update posted
- Aug 8, 2023
2018 – 2023
United States locations
- U.S. sites
- 60
- U.S. states
- 25
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Andalusia | Andalusia | Alabama | 36420 | — |
| Scottsdale | Scottsdale | Arizona | 85251 | — |
| Tucson | Tucson | Arizona | 85704 | — |
| Tuscon | Tucson | Arizona | 85712 | — |
| Canoga Park | Canoga Park | California | 91303 | — |
| Los Angeles | Los Angeles | California | 70433 | — |
| San Diego | San Diego | California | 92111 | — |
| Greenwood Village | Greenwood Village | Colorado | 80111 | — |
| Washington | Washington D.C. | District of Columbia | 20036 | — |
| Aventura | Aventura | Florida | 33180 | — |
| Fort Myers | Fort Myers | Florida | 33912 | — |
| Hialeah | Hialeah | Florida | 33012 | — |
| Hialeah | Hialeah | Florida | 33016 | — |
| Margate | Margate | Florida | 33063 | — |
| Miami | Miami | Florida | 33126 | — |
| Miami | Miami | Florida | 33155 | — |
| Sarasota | Sarasota | Florida | 34239 | — |
| Tampa | Tampa | Florida | 33606 | — |
| Atlanta | Atlanta | Georgia | 30312 | — |
| Atlanta | Atlanta | Georgia | 30363 | — |
| Augusta | Augusta | Georgia | 30909 | — |
| Norcross | Norcross | Georgia | 30093 | — |
| Idaho Falls | Idaho Falls | Idaho | 83404 | — |
| Oakbrook | Oakbrook Terrace | Illinois | 60523 | — |
| Park Ridge | Park Ridge | Illinois | 60068 | — |
| Shawnee | Shawnee Mission | Kansas | 66218 | — |
| Marrero | Marrero | Louisiana | 70072 | — |
| Towson | Towson | Maryland | 21204 | — |
| Saginaw | Saginaw | Michigan | 48602 | — |
| Jefferson City | Jefferson City | Missouri | 65109 | — |
| St. Louis | St Louis | Missouri | 63141 | — |
| Omaha | Omaha | Nebraska | 68130 | — |
| Las Vegas | Las Vegas | Nevada | 89113 | — |
| Durham | Durham | North Carolina | 27713 | — |
| New Bern | New Bern | North Carolina | 28562 | — |
| Winston Salem | Winston-Salem | North Carolina | 27103 | — |
| Akron | Akron | Ohio | 44313 | — |
| Columbus | Columbus | Ohio | 43235 | — |
| Englewood | Englewood | Ohio | 45322 | — |
| Hershey | Hershey | Pennsylvania | 17033-0850 | — |
| Columbia | Columbia | South Carolina | 29201 | — |
| Chattanooga | Chattanooga | Tennessee | 37404 | — |
| Memphis | Memphis | Tennessee | 38120 | — |
| Beaumont | Beaumont | Texas | 77702 | — |
| Corpus Christi | Corpus Christi | Texas | 78412 | — |
| Dallas | Dallas | Texas | 75231 | — |
| Fort Worth | Fort Worth | Texas | 76104 | — |
| Houston | Houston | Texas | 77030 | — |
| Houston | Houston | Texas | 77054 | — |
| Irving | Irving | Texas | 75062 | — |
| San Antonio | San Antonio | Texas | 78258 | — |
| Sugar Land | Sugar Land | Texas | 77479 | — |
| Webster | Webster | Texas | 77598 | — |
| Salt Lake City | Salt Lake City | Utah | 84102 | — |
| Salt Lake City | Salt Lake City | Utah | 84107 | — |
| Salt Lake City | Salt Lake City | Utah | 84124 | — |
| Norfolk | Norfolk | Virginia | 23507 | — |
| Richmond | Richmond | Virginia | 23235 | — |
| Virginia Beach | Virginia Beach | Virginia | 23502 | — |
| Seattle | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 109 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03654274, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 8, 2023 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03654274 live on ClinicalTrials.gov.