ClinicalTrials.gov record
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
ClinicalTrials.gov ID: NCT03070899
Public ClinicalTrials.gov record NCT03070899. 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 3, Multicentre, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Daily Oral Administration of OBE2109 Alone and in Combination With Add-back Therapy 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 primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Study identification
- NCT ID
- NCT03070899
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 526 participants
Conditions and interventions
Conditions
Interventions
- OBE2109 Drug
- Placebo to match OBE2109 Drug
- Placebo to match Add-back Drug
- Add-back Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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 20, 2017 (Actual)
- Primary completion
- Apr 14, 2020 (Actual)
- Completion
- Apr 12, 2021 (Actual)
- Last update posted
- Jun 9, 2021
2017 – 2021
United States locations
- U.S. sites
- 116
- U.S. states
- 28
- U.S. cities
- 96
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site reference ID 192 | Birmingham | Alabama | 35205 | — |
| Site reference ID 169 | Dothan | Alabama | 33016 | — |
| Site reference ID 353 | Mobile | Alabama | 36608 | — |
| Site reference ID 232 | Vestavia Hills | Alabama | 35216 | — |
| Site reference ID 242 | Phoenix | Arizona | 85015 | — |
| Site reference ID 355 | Tucson | Arizona | 85712 | — |
| Site reference ID 211 | Arcadia | California | 91007 | — |
| Site reference ID 184 | Cerritos | California | 90703 | — |
| Site reference ID 147 | Escondido | California | 92866 | — |
| Site reference ID 154 | Huntington Park | California | 90255 | — |
| Site reference ID 185 | Los Angeles | California | 90255 | — |
| Site reference ID 199 | Northridge | California | 91324 | — |
| Site reference ID 111 | Panorama City | California | 91402 | — |
| Site reference ID 166 | Sacramento | California | 95821 | — |
| Site reference ID 101 | San Diego | California | 92108 | — |
| Site reference ID 239 | Upland | California | 91786 | — |
| Site reference ID 112 | Westminster | California | 92683 | — |
| Site reference ID 144 | Denver | Colorado | 80246 | — |
| Site reference ID 246 | Englewood | Colorado | 80112 | — |
| Site reference ID 234 | Thornton | Colorado | 80229 | — |
| Site reference ID 189 | New Haven | Connecticut | 06519 | — |
| Site reference ID 105 | Washington D.C. | District of Columbia | 20036 | — |
| Site reference ID 231 | Boca Raton | Florida | 33433 | — |
| Site reference ID 190 | Boca Raton | Florida | 33486 | — |
| Site reference ID 168 | Clearwater | Florida | 33759 | — |
| Site reference ID 233 | DeLand | Florida | 32720 | — |
| Site reference ID 197 | Fort Lauderdale | Florida | 33316 | — |
| Site reference ID 135 | Hialeah | Florida | 33012 | — |
| Site reference ID 146 | Hialeah | Florida | 33012 | — |
| Site reference ID 191 | Jacksonville | Florida | 32256 | — |
| Site reference ID 204 | Loxahatchee Groves | Florida | 33470 | — |
| Site reference ID 137 | Miami | Florida | 33130 | — |
| Site reference ID 142 | Miami | Florida | 33144 | — |
| Site reference ID 110 | Miami | Florida | 33165 | — |
| Site reference ID 106 | Miami | Florida | 33176 | — |
| Site reference ID 127 | Miami | Florida | 33176 | — |
| Site reference ID 117 | Miami Lakes | Florida | 33016 | — |
| Site reference ID 134 | Miami Lakes | Florida | 33016 | — |
| Site reference ID 129 | Miami Springs | Florida | 33166 | — |
| Site reference ID 107 | Miramar | Florida | 33027 | — |
| Site reference ID 124 | New Port Richey | Florida | 34653 | — |
| Site reference ID 141 | Orlando | Florida | 32801 | — |
| Site reference ID 140 | Orlando | Florida | 32806 | — |
| Site reference ID 207 | St. Petersburg | Florida | 33709 | — |
| Site reference ID 113 | Tampa | Florida | 33613 | — |
| Site reference ID 163 | Columbus | Georgia | 31904 | — |
| Site reference ID 158 | Norcross | Georgia | 30092 | — |
| Site reference ID 151 | Norcross | Georgia | 30093 | — |
| Site reference ID 150 | Sandy Springs | Georgia | 30328 | — |
| Site reference ID 359 | Idaho Falls | Idaho | 83404 | — |
| Site reference ID 352 | Meridian | Idaho | 83642 | — |
| Site reference ID 174 | Champaign | Illinois | 61820 | — |
| Site reference ID 182 | Oak Brook | Illinois | 60523 | — |
| Site reference ID 178 | Shawnee Mission | Kansas | 66218 | — |
| Site reference ID 354 | Wichita | Kansas | 67207 | — |
| Site reference ID 176 | Lake Charles | Louisiana | 70601 | — |
| Site reference ID 109 | Marrero | Louisiana | 70072 | — |
| Site reference ID 248 | Frederick | Maryland | 21702 | — |
| Site reference ID 226 | Silver Spring | Maryland | 20910 | — |
| Site reference ID 228 | Towson | Maryland | 21204 | — |
| Site reference ID 149 | Fall River | Massachusetts | 02720 | — |
| Site reference ID 126 | Fall River | Massachusetts | 02721 | — |
| Site reference ID 100 | Bay City | Michigan | 48706 | — |
| Site reference ID 145 | Detroit | Michigan | 48034 | — |
| Site reference ID 214 | Saginaw | Michigan | 48602 | — |
| Site reference ID 170 | Saginaw | Michigan | 48604 | — |
| Site reference ID 138 | Missoula | Montana | 59808 | — |
| Site reference ID 236 | Las Vegas | Nevada | 89109 | — |
| Site reference ID 245 | Lawrenceville | New Jersey | 08648 | — |
| Site reference ID 175 | Brooklyn | New York | 11203 | — |
| Site reference ID 188 | New York | New York | 10016 | — |
| Site reference ID 208 | Port Jefferson | New York | 11764 | — |
| Site reference ID 133 | Staten Island | New York | 10306 | — |
| Site reference ID 104 | Greensboro | North Carolina | 27408 | — |
| Site reference ID 131 | Morehead City | North Carolina | 28557 | — |
| Site reference ID 102 | Raleigh | North Carolina | 27607 | — |
| Site reference ID 187 | Southern Pines | North Carolina | 28374 | — |
| Site reference ID 119 | Winston-Salem | North Carolina | 27103 | — |
| Site reference ID 186 | Cincinnati | Ohio | 45212 | — |
| Site reference ID 164 | Cleveland | Ohio | 44122 | — |
| Site reference ID 230 | Fairfield | Ohio | 45014 | — |
| Site reference ID 213 | Franklin | Ohio | 45005 | — |
| Site reference ID 116 | Bryn Mawr | Pennsylvania | 19010 | — |
| Site reference ID 195 | Hershey | Pennsylvania | 17033 | — |
| Site reference ID 222 | Indiana | Pennsylvania | 15701 | — |
| Site reference ID 165 | Jenkintown | Pennsylvania | 19046 | — |
| Site reference ID 210 | Pittsburgh | Pennsylvania | 15243 | — |
| Site reference ID 148 | Smithfield | Pennsylvania | 15478 | — |
| Site reference ID 351 | North Charleston | South Carolina | 29406 | — |
| Site reference ID 358 | Spartanburg | South Carolina | 29301 | — |
| Site reference ID 159 | Chattanooga | Tennessee | 37404 | — |
| Site reference ID 235 | Knoxville | Tennessee | 37920 | — |
| Site reference ID 205 | Memphis | Tennessee | 38119 | — |
| Site reference ID 180 | Memphis | Tennessee | 38120 | — |
| Site reference ID 238 | Austin | Texas | 78726 | — |
| Site reference ID 155 | Austin | Texas | 78758 | — |
| Site reference ID 201 | Beaumont | Texas | 77702 | — |
| Site reference ID 247 | Corpus Christi | Texas | 78412 | — |
| Site reference ID 183 | Dallas | Texas | 75231 | — |
| Site reference ID 216 | Dallas | Texas | 75231 | — |
| Site reference ID 200 | Dallas | Texas | 75234 | — |
| Site reference ID 250 | Fort Worth | Texas | 76104 | — |
| Site reference ID 244 | Fort Worth | Texas | 76132 | — |
| Site reference ID 115 | Frisco | Texas | 75035 | — |
| Site reference ID 157 | Houston | Texas | 77030 | — |
| Site reference ID 120 | Houston | Texas | 77054 | — |
| Site reference ID 219 | Houston | Texas | 77071 | — |
| Site reference ID 217 | Houston | Texas | 77074 | — |
| Site reference ID 218 | Pasadena | Texas | 77505 | — |
| Site reference ID 172 | San Antonio | Texas | 78258 | — |
| Site reference ID 128 | Webster | Texas | 77598 | — |
| Site reference ID 125 | West Jordan | Utah | 84088 | — |
| Site reference ID 103 | Norfolk | Virginia | 23507 | — |
| Site reference ID 171 | Norfolk | Virginia | 23507 | — |
| Site reference ID 123 | Richmond | Virginia | 23233 | — |
| Site reference ID 237 | Bellevue | Washington | 98007 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03070899, 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 9, 2021 · 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 NCT03070899 live on ClinicalTrials.gov.