SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain
Public ClinicalTrials.gov record NCT03204318. 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 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered With and Without 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 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.
Study identification
- NCT ID
- NCT03204318
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 638 participants
Conditions and interventions
Conditions
Interventions
- Relugolix Drug
- Estradiol/norethindrone acetate Drug
- Estradiol/norethindrone acetate placebo Drug
- Relugolix placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 50 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
- Dec 7, 2017 (Actual)
- Primary completion
- Jun 9, 2020 (Actual)
- Completion
- Apr 8, 2021 (Actual)
- Last update posted
- Jun 28, 2021
2017 – 2021
United States locations
- U.S. sites
- 43
- U.S. states
- 21
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dothan | Dothan | Alabama | 36303 | — |
| Mesa | Mesa | Arizona | 85209 | — |
| Scottsdale | Scottsdale | Arizona | 85251 | — |
| Tucson | Tucson | Arizona | 85704 | — |
| Tucson | Tucson | Arizona | 85712 | — |
| Canoga Park | Canoga Park | California | 91303 | — |
| Long Beach | Long Beach | California | 90806 | — |
| San Diego | San Diego | California | 92111 | — |
| Greenwood Village | Greenwood Village | Colorado | 80111 | — |
| Fort Myers | Fort Myers | Florida | 33912 | — |
| Loxahatchee | Loxahatchee Groves | Florida | 33470 | — |
| Miami | Miami | Florida | 33126 | — |
| Miami | Miami | Florida | 33155 | — |
| Orlando | Orlando | Florida | 32808 | — |
| Oviedo | Oviedo | Florida | 32765 | — |
| Plantation | Plantation | Florida | 33324 | — |
| Sarasota | Sarasota | Florida | 34239 | — |
| Atlanta | Atlanta | Georgia | 30363 | — |
| Augusta | Augusta | Georgia | 30909 | — |
| Norcross | Norcross | Georgia | 30093 | — |
| Idaho Falls | Idaho Falls | Idaho | 83404 | — |
| Oakbrook | Oak Brook | Illinois | 60523 | — |
| Shawnee | Shawnee Mission | Kansas | 66218 | — |
| New Orleans | New Orleans | Louisiana | 70115 | — |
| Jefferson City | Jefferson City | Missouri | 65109 | — |
| Las Vegas | Las Vegas | Nevada | 89113 | — |
| Port Jefferson | Port Jefferson | New York | 11777 | — |
| Durham | Durham | North Carolina | 27713 | — |
| Raleigh | Raleigh | North Carolina | 27612 | — |
| Winston Salem | Winston-Salem | North Carolina | 27103 | — |
| Englewood | Englewood | Ohio | 45322 | — |
| Hershey | Hershey | Pennsylvania | 17033 | — |
| Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Memphis | Memphis | Tennessee | 38120 | — |
| Murfreesboro | Murfreesboro | Tennessee | 37130 | — |
| Austin | Austin | Texas | 78705 | — |
| Houston | Houston | Texas | 77030 | — |
| Webster | Webster | Texas | 77598 | — |
| Salt Lake City | Salt Lake City | Utah | 84107 | — |
| Salt Lake City | Salt Lake City | Utah | 84124 | — |
| Norfolk | Norfolk | Virginia | 23507 | — |
| Richmond | Richmond | Virginia | 23235 | — |
| 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 80 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03204318, 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 Jun 28, 2021 · Synced Oct 21, 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 NCT03204318 live on ClinicalTrials.gov.