LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Public ClinicalTrials.gov record NCT03049735. 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
LIBERTY 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
Study identification
- NCT ID
- NCT03049735
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 388 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
- Apr 26, 2017 (Actual)
- Primary completion
- Apr 29, 2019 (Actual)
- Completion
- Aug 24, 2020 (Actual)
- Last update posted
- Apr 19, 2022
2017 – 2020
United States locations
- U.S. sites
- 76
- U.S. states
- 25
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Andalusia | Andalusia | Alabama | 36420 | — |
| Mobile | Mobile | Alabama | 36608 | — |
| Little Rock | Little Rock | Arkansas | 72205 | — |
| La Mesa | La Mesa | California | 91942 | — |
| Lomita | Lomita | California | 90717 | — |
| Norwalk | Norwalk | California | 90650 | — |
| Oceanside | Oceanside | California | 92056 | — |
| San Diego | San Diego | California | 92108 | — |
| San Diego | San Diego | California | 92111 | — |
| Denver | Denver | Colorado | 80209 | — |
| Aventura | Aventura | Florida | 33180 | — |
| Brandon | Brandon | Florida | 33510 | — |
| Clearwater | Clearwater | Florida | 33759 | — |
| Clermont | Clermont | Florida | 34711 | — |
| Fort Myers | Fort Myers | Florida | 33912 | — |
| Hialeah | Hialeah | Florida | 33012 | — |
| Hialeah | Hialeah | Florida | 33016 | — |
| Jacksonville | Jacksonville | Florida | 32207 | — |
| Lauderdale Lakes | Lauderdale Lakes | Florida | 33319 | — |
| Margate | Margate | Florida | 33063 | — |
| Miami | Miami | Florida | 33155 | — |
| Miami | Miami | Florida | 33165 | — |
| Miami | Miami | Florida | 33176 | — |
| Orlando | Orlando | Florida | 32806 | — |
| Orlando | Orlando | Florida | 32808 | — |
| Palm Harbor | Palm Harbor | Florida | 34684 | — |
| South Miami | South Miami | Florida | 33143 | — |
| Tampa | Tampa | Florida | 33613 | — |
| West Palm Beach | West Palm Beach | Florida | 33409 | — |
| Weston | Weston | Florida | 33327 | — |
| Atlanta | Atlanta | Georgia | 30342 | — |
| Atlanta | Atlanta | Georgia | 49074 | — |
| Augusta | Augusta | Georgia | 30912 | — |
| College Park | College Park | Georgia | 30349 | — |
| Richland | Richland | Georgia | 99352 | — |
| Oakbrook | Oakbrook Terrace | Illinois | 60523 | — |
| Lafayette | Lafayette | Indiana | 47905 | — |
| Covington | Covington | Louisiana | 70433 | — |
| Shreveport | Shreveport | Louisiana | 71118 | — |
| St. Louis | St Louis | Missouri | 63141 | — |
| Lincoln | Lincoln | Nebraska | 68510 | — |
| Omaha | Omaha | Nebraska | 68124 | — |
| Las Vegas | Las Vegas | Nevada | 89106 | — |
| Las Vegas | Las Vegas | Nevada | 89128 | — |
| Lawrenceville | Lawrenceville | New Jersey | 08648 | — |
| Albuquerque | Albuquerque | New Mexico | 87109 | — |
| Williamsville | Williamsville | New York | 14221 | — |
| Durham | Durham | North Carolina | 27713 | — |
| Morehead City | Morehead City | North Carolina | 28557 | — |
| Raleigh | Raleigh | North Carolina | 27612 | — |
| Bismarck | Bismarck | North Dakota | 58501 | — |
| Fargo | Fargo | North Dakota | 58103 | — |
| Minot | Minot | North Dakota | 58701 | — |
| Cincinnati | Cincinnati | Ohio | 45219 | — |
| Cincinnati | Cincinnati | Ohio | 45267 | — |
| Dayton | Dayton | Ohio | 45409 | — |
| Englewood | Englewood | Ohio | 45322 | — |
| Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Bluffton | Bluffton | South Carolina | 29910 | — |
| Charleston | Charleston | South Carolina | 29406 | — |
| Columbia | Columbia | South Carolina | 29201 | — |
| Greenville | Greenville | South Carolina | 29605 | — |
| Chattanooga | Chattanooga | Tennessee | 37404 | — |
| Memphis | Memphis | Tennessee | 38119 | — |
| Memphis | Memphis | Tennessee | 38120 | — |
| Fort Worth | Fort Worth | Texas | 76104 | — |
| Houston | Houston | Texas | 77054 | — |
| Houston | Houston | Texas | 77074 | — |
| Irving | Irving | Texas | 75062 | — |
| San Antonio | San Antonio | Texas | 78229 | — |
| Sugar Land | Sugar Land | Texas | 77479 | — |
| Webster | Webster | Texas | 77598 | — |
| Salt Lake City | Salt Lake City | Utah | 84107 | — |
| Salt Lake City | Salt Lake City | Utah | 84124 | — |
| Norfolk | Norfolk | Virginia | 23507 | — |
| 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 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03049735, 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 Apr 19, 2022 · Synced Oct 20, 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 NCT03049735 live on ClinicalTrials.gov.