Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
NCT ID: NCT03070899
Last Updated: 2021-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
526 participants
INTERVENTIONAL
2017-04-20
2021-04-12
Brief Summary
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Detailed Description
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Subjects will be randomized to one of 5 treatment groups in a 1:1:1:1:1 ratio.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OBE2109 dose 1 (100mg) + Placebo Add-back
OBE2109
OBE2109 100mg tablets for oral administration once daily
Placebo to match OBE2109
Placebo to match OBE2109 100mg tablets for oral administration once daily
Placebo to match Add-back
Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
OBE2109 dose 1 (100mg) + Add-back
OBE2109
OBE2109 100mg tablets for oral administration once daily
Placebo to match OBE2109
Placebo to match OBE2109 100mg tablets for oral administration once daily
Add-back
Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back
OBE2109
OBE2109 100mg tablets for oral administration once daily
Placebo to match Add-back
Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Add-back
Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
OBE2109 dose 2 (200mg) + Add-back
OBE2109
OBE2109 100mg tablets for oral administration once daily
Add-back
Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back
At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.
OBE2109
OBE2109 100mg tablets for oral administration once daily
Placebo to match OBE2109
Placebo to match OBE2109 100mg tablets for oral administration once daily
Placebo to match Add-back
Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Add-back
Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Interventions
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OBE2109
OBE2109 100mg tablets for oral administration once daily
Placebo to match OBE2109
Placebo to match OBE2109 100mg tablets for oral administration once daily
Placebo to match Add-back
Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Add-back
Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index ≥ 18 kg/m2.
* Menstrual cycles ≥ 21 days and ≤ 40 days.
* Presence of uterine fibroids.
* Heavy menstrual blood loss for each of the 2 menstrual periods assessed at screening using the alkaline hematin method.
Exclusion Criteria
* History of uterus surgery that would interfere with the study.
* The subject's condition is so severe that she will require surgery within 6 months regardless of the treatment provided.
* Undiagnosed abnormal uterine bleeding.
* Significant risk of osteoporosis or history of, or known osteoporosis or other metabolic bone disease.
18 Years
FEMALE
No
Sponsors
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ObsEva SA
INDUSTRY
Responsible Party
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Principal Investigators
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ObsEva SA
Role: STUDY_DIRECTOR
Geneva
Locations
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Site reference ID 192
Birmingham, Alabama, United States
Site reference ID 169
Dothan, Alabama, United States
Site reference ID 353
Mobile, Alabama, United States
Site reference ID 232
Vestavia Hills, Alabama, United States
Site reference ID 242
Phoenix, Arizona, United States
Site reference ID 355
Tucson, Arizona, United States
Site reference ID 211
Arcadia, California, United States
Site reference ID 184
Cerritos, California, United States
Site reference ID 147
Escondido, California, United States
Site reference ID 154
Huntington Park, California, United States
Site reference ID 185
Los Angeles, California, United States
Site reference ID 199
Northridge, California, United States
Site reference ID 111
Panorama City, California, United States
Site reference ID 166
Sacramento, California, United States
Site reference ID 101
San Diego, California, United States
Site reference ID 239
Upland, California, United States
Site reference ID 112
Westminster, California, United States
Site reference ID 144
Denver, Colorado, United States
Site reference ID 246
Englewood, Colorado, United States
Site reference ID 234
Thornton, Colorado, United States
Site reference ID 189
New Haven, Connecticut, United States
Site reference ID 105
Washington D.C., District of Columbia, United States
Site reference ID 231
Boca Raton, Florida, United States
Site reference ID 190
Boca Raton, Florida, United States
Site reference ID 168
Clearwater, Florida, United States
Site reference ID 233
DeLand, Florida, United States
Site reference ID 197
Fort Lauderdale, Florida, United States
Site reference ID 135
Hialeah, Florida, United States
Site reference ID 146
Hialeah, Florida, United States
Site reference ID 191
Jacksonville, Florida, United States
Site reference ID 204
Loxahatchee Groves, Florida, United States
Site reference ID 137
Miami, Florida, United States
Site reference ID 142
Miami, Florida, United States
Site reference ID 110
Miami, Florida, United States
Site reference ID 106
Miami, Florida, United States
Site reference ID 127
Miami, Florida, United States
Site reference ID 117
Miami Lakes, Florida, United States
Site reference ID 134
Miami Lakes, Florida, United States
Site reference ID 129
Miami Springs, Florida, United States
Site reference ID 107
Miramar, Florida, United States
Site reference ID 124
New Port Richey, Florida, United States
Site reference ID 141
Orlando, Florida, United States
Site reference ID 140
Orlando, Florida, United States
Site reference ID 207
St. Petersburg, Florida, United States
Site reference ID 113
Tampa, Florida, United States
Site reference ID 163
Columbus, Georgia, United States
Site reference ID 158
Norcross, Georgia, United States
Site reference ID 151
Norcross, Georgia, United States
Site reference ID 150
Sandy Springs, Georgia, United States
Site reference ID 359
Idaho Falls, Idaho, United States
Site reference ID 352
Meridian, Idaho, United States
Site reference ID 174
Champaign, Illinois, United States
Site reference ID 182
Oak Brook, Illinois, United States
Site reference ID 178
Shawnee Mission, Kansas, United States
Site reference ID 354
Wichita, Kansas, United States
Site reference ID 176
Lake Charles, Louisiana, United States
Site reference ID 109
Marrero, Louisiana, United States
Site reference ID 248
Frederick, Maryland, United States
Site reference ID 226
Silver Spring, Maryland, United States
Site reference ID 228
Towson, Maryland, United States
Site reference ID 149
Fall River, Massachusetts, United States
Site reference ID 126
Fall River, Massachusetts, United States
Site reference ID 100
Bay City, Michigan, United States
Site reference ID 145
Detroit, Michigan, United States
Site reference ID 214
Saginaw, Michigan, United States
Site reference ID 170
Saginaw, Michigan, United States
Site reference ID 138
Missoula, Montana, United States
Site reference ID 236
Las Vegas, Nevada, United States
Site reference ID 245
Lawrenceville, New Jersey, United States
Site reference ID 175
Brooklyn, New York, United States
Site reference ID 188
New York, New York, United States
Site reference ID 208
Port Jefferson, New York, United States
Site reference ID 133
Staten Island, New York, United States
Site reference ID 104
Greensboro, North Carolina, United States
Site reference ID 131
Morehead City, North Carolina, United States
Site reference ID 102
Raleigh, North Carolina, United States
Site reference ID 187
Southern Pines, North Carolina, United States
Site reference ID 119
Winston-Salem, North Carolina, United States
Site reference ID 186
Cincinnati, Ohio, United States
Site reference ID 164
Cleveland, Ohio, United States
Site reference ID 230
Fairfield, Ohio, United States
Site reference ID 213
Franklin, Ohio, United States
Site reference ID 116
Bryn Mawr, Pennsylvania, United States
Site reference ID 195
Hershey, Pennsylvania, United States
Site reference ID 222
Indiana, Pennsylvania, United States
Site reference ID 165
Jenkintown, Pennsylvania, United States
Site reference ID 210
Pittsburgh, Pennsylvania, United States
Site reference ID 148
Smithfield, Pennsylvania, United States
Site reference ID 351
North Charleston, South Carolina, United States
Site reference ID 358
Spartanburg, South Carolina, United States
Site reference ID 159
Chattanooga, Tennessee, United States
Site reference ID 235
Knoxville, Tennessee, United States
Site reference ID 205
Memphis, Tennessee, United States
Site reference ID 180
Memphis, Tennessee, United States
Site reference ID 238
Austin, Texas, United States
Site reference ID 155
Austin, Texas, United States
Site reference ID 201
Beaumont, Texas, United States
Site reference ID 247
Corpus Christi, Texas, United States
Site reference ID 183
Dallas, Texas, United States
Site reference ID 216
Dallas, Texas, United States
Site reference ID 200
Dallas, Texas, United States
Site reference ID 250
Fort Worth, Texas, United States
Site reference ID 244
Fort Worth, Texas, United States
Site reference ID 115
Frisco, Texas, United States
Site reference ID 157
Houston, Texas, United States
Site reference ID 120
Houston, Texas, United States
Site reference ID 219
Houston, Texas, United States
Site reference ID 217
Houston, Texas, United States
Site reference ID 218
Pasadena, Texas, United States
Site reference ID 172
San Antonio, Texas, United States
Site reference ID 128
Webster, Texas, United States
Site reference ID 125
West Jordan, Utah, United States
Site reference ID 103
Norfolk, Virginia, United States
Site reference ID 171
Norfolk, Virginia, United States
Site reference ID 123
Richmond, Virginia, United States
Site reference ID 237
Bellevue, Washington, United States
Countries
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References
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Donnez J, Petraglia F, Taylor H, Becker CM, Becker S, Herrera FC, Bestel E, Hori S, Dolmans MM. Linzagolix with and without hormonal add-back therapy for symptomatic uterine fibroids: PRIMROSE 1 & 2 long-term extension and withdrawal study. Fertil Steril. 2025 Oct;124(4):737-748. doi: 10.1016/j.fertnstert.2025.06.016. Epub 2025 Jun 19.
Becker S, Dolmans MM, Herrera FC, Petraglia F, Renner SP, Ionescu-Ittu R, St-Pierre J, Boolell M, Bestel E, Hori S, Donnez J. Pain Reduction in Linzagolix-Treated Patients With Uterine Fibroids: A Secondary Mediation Analysis of the PRIMROSE 1 and 2 Phase 3 Trials. BJOG. 2025 Aug;132(9):1297-1306. doi: 10.1111/1471-0528.18190. Epub 2025 May 6.
Donnez J, Taylor HS, Stewart EA, Bradley L, Marsh E, Archer D, Al-Hendy A, Petraglia F, Watts N, Gotteland JP, Bestel E, Terrill P, Loumaye E, Humberstone A, Garner E. Linzagolix with and without hormonal add-back therapy for the treatment of symptomatic uterine fibroids: two randomised, placebo-controlled, phase 3 trials. Lancet. 2022 Sep 17;400(10356):896-907. doi: 10.1016/S0140-6736(22)01475-1.
Other Identifiers
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16-OBE2109-008
Identifier Type: -
Identifier Source: org_study_id
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