A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Public ClinicalTrials.gov record NCT03886220. 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
A Phase 4 Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.
Study identification
- NCT ID
- NCT03886220
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 82 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
- Apr 12, 2019 (Actual)
- Primary completion
- Mar 31, 2021 (Actual)
- Completion
- Apr 28, 2021 (Actual)
- Last update posted
- Mar 31, 2022
2019 – 2021
United States locations
- U.S. sites
- 45
- U.S. states
- 18
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ACCEL Research Sites /ID# 209714 | Birmingham | Alabama | 35218 | — |
| University of Alabama at Birmingham - Women's and Infant's Center /ID# 209581 | Birmingham | Alabama | 35294-7333 | — |
| Unity Health- Searcy Medical Center /ID# 210905 | Searcy | Arkansas | 72143-4802 | — |
| Grossmont Ctr Clin Research /ID# 217690 | La Mesa | California | 91942 | — |
| Women's Health Care Research Corp /ID# 211472 | San Diego | California | 92111-3738 | — |
| Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 213764 | Fort Myers | Florida | 33912 | — |
| Caceres Specialized Gynecology /ID# 214956 | Kissimmee | Florida | 34741 | — |
| LCC Medical Research Institute /ID# 213765 | Miami | Florida | 33126 | — |
| Genoma Research Group, Inc /ID# 213771 | Miami | Florida | 33165 | — |
| A Premier Medical Research of FL /ID# 214947 | Orange City | Florida | 32763-2833 | — |
| GCP Clinical Research, LLC /ID# 218742 | Tampa | Florida | 33609-3588 | — |
| Comprehensive Clinical Trials LLC /ID# 217177 | West Palm Beach | Florida | 33409 | — |
| Georgia Research for Women /ID# 211321 | Atlanta | Georgia | 30312-1200 | — |
| Atlanta Women's Research Institute /ID# 217745 | Atlanta | Georgia | 30342 | — |
| Medisense Inc /ID# 217750 | Atlanta | Georgia | 30363 | — |
| Women's Health of Augusta /ID# 214995 | Augusta | Georgia | 30901-2775 | — |
| Midtown OBGYN North /ID# 209391 | Columbus | Georgia | 31909-5715 | — |
| Journey Medical Research Institute - Snellville /ID# 217309 | Snellville | Georgia | 30078-6191 | — |
| Affinity Clinical Research /ID# 215252 | Oak Brook | Illinois | 60523-1245 | — |
| Clinical Trials Management, LLC - Covington /ID# 215020 | Covington | Louisiana | 70433 | — |
| Southern Clinical Research A /ID# 213732 | Metairie | Louisiana | 70001 | — |
| Johns Hopkins University /ID# 211135 | Baltimore | Maryland | 21287 | — |
| NECCR Fall River LLC /ID# 215009 | Fall River | Massachusetts | 02720-2972 | — |
| Excel Clinical Research /ID# 215936 | Las Vegas | Nevada | 89109 | — |
| Manhattan Medical Research /ID# 213753 | New York | New York | 10016-6023 | — |
| Upstate Clinical Research Associates /ID# 215156 | Williamsville | New York | 14221-6046 | — |
| M3 Wake Research Inc. /ID# 215166 | Raleigh | North Carolina | 27612-8106 | — |
| Carolina Medical Trials - Winston-Salem /ID# 215027 | Winston-Salem | North Carolina | 27103-4109 | — |
| Legacy Medical Group-Gynecologic Oncology /ID# 211016 | Portland | Oregon | 97210-2900 | — |
| Clinical Research of Philadelphia, LLC /ID# 213741 | Philadelphia | Pennsylvania | 19114 | — |
| Reading Hospital Clinical Trials Office /ID# 213763 | West Reading | Pennsylvania | 19611 | — |
| Clinical Trials of SC /ID# 210204 | Charleston | South Carolina | 29406 | — |
| Chattanooga Medical Research /ID# 215294 | Chattanooga | Tennessee | 37404 | — |
| WR-Medical Research Center of Memphis LLC /ID# 213756 | Memphis | Tennessee | 38120-8328 | — |
| Access Clinical Trials, Inc. /ID# 215357 | Nashville | Tennessee | 37203 | — |
| Signature Gyn Services /ID# 213883 | Fort Worth | Texas | 76104 | — |
| FMC Science, LLC - OB/GYN - Georgetown /ID# 211164 | Georgetown | Texas | 78626-8185 | — |
| University of Texas (UT) Health Women's Research Center at Memorial City /ID# 215193 | Houston | Texas | 77024-2515 | — |
| Advances in Health, Inc. /ID# 215847 | Houston | Texas | 77030 | — |
| Clinical Trials of Texas, Inc /ID# 213768 | San Antonio | Texas | 78229 | — |
| Discovery Clinical Trials-San Antonio /ID# 214996 | San Antonio | Texas | 78258 | — |
| Storks Research, LLC /ID# 211146 | Sugar Land | Texas | 77479-1285 | — |
| Houston Ctr for Clin Research /ID# 215138 | Sugar Land | Texas | 77479 | — |
| Seattle Clinical Research Center /ID# 210853 | Seattle | Washington | 98105 | — |
| North Spokane Women's Health /ID# 209889 | Spokane | Washington | 99207 | — |
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 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03886220, 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 Mar 31, 2022 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03886220 live on ClinicalTrials.gov.