Clinical trial NCT03070899: Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Fibroids
Heavy Menstrual Bleeding
Keywords: Uterine Fibroid
Leiomyomata
Heavy Menstrual Bleeding
HMB
Heavy Uterine Bleeding
Menorrhagia
OBE2109 + Add-back
Lead sponsor: ObsEva SA
Sponsor class: INDUSTRY
First posted: 2017-03-06
Enrollment: 526
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of OBE2109 alone and in combination with add-back therapy for the treatment of uterine fibroids.

Subjects will be randomized to one of 5 treatment groups in a 1:1:1:1:1 ratio.

Eligibility criteria: Key Inclusion Criteria:

* Premenopausal woman at screening.
* 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.

Key Exclusion Criteria:

* The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study.
* 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.

Primary outcomes:
measure: Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24
timeFrame: From baseline to Week 24
Secondary outcomes:
measure: Time to reduced menstrual blood loss
timeFrame: Up to Week 52
measure: Amenorrhea
timeFrame: Up to Week 52
measure: Time to amenorrhea
timeFrame: Up to Week 52
measure: Number of days of uterine bleeding for the last 28-day interval prior to Week 24
timeFrame: last 28-day interval prior to Week 24
measure: Number of days of uterine bleeding for each 28-day interval
timeFrame: Up to Week 52
Other outcomes:
measure: Bone Mineral Density (BMD)
timeFrame: From baseline up to Week 76
measure: Endometrial biopsy
timeFrame: From baseline up to Week 52
measure: Adverse events
timeFrame: Up to Week 76
Locations:
city: Birmingham
country: United States
facility: Site reference ID 192
state: Alabama
city: Dothan
country: United States
facility: Site reference ID 169
state: Alabama
city: Mobile
country: United States
facility: Site reference ID 353
state: Alabama
city: Vestavia Hills
country: United States
facility: Site reference ID 232
state: Alabama
city: Phoenix
country: United States
facility: Site reference ID 242
state: Arizona
city: Tucson
country: United States
facility: Site reference ID 355
state: Arizona
city: Arcadia
country: United States
facility: Site reference ID 211
state: California
city: Cerritos
country: United States
facility: Site reference ID 184
state: California
city: Escondido
country: United States
facility: Site reference ID 147
state: California
city: Huntington Park
country: United States
facility: Site reference ID 154
state: California
city: Los Angeles
country: United States
facility: Site reference ID 185
state: California
city: Northridge
country: United States
facility: Site reference ID 199
state: California
city: Panorama City
country: United States
facility: Site reference ID 111
state: California
city: Sacramento
country: United States
facility: Site reference ID 166
state: California
city: San Diego
country: United States
facility: Site reference ID 101
state: California
city: Upland
country: United States
facility: Site reference ID 239
state: California
city: Westminster
country: United States
facility: Site reference ID 112
state: California
city: Denver
country: United States
facility: Site reference ID 144
state: Colorado
city: Englewood
country: United States
facility: Site reference ID 246
state: Colorado
city: Thornton
country: United States
facility: Site reference ID 234
state: Colorado
city: New Haven
country: United States
facility: Site reference ID 189
state: Connecticut
city: Washington
country: United States
facility: Site reference ID 105
state: District of Columbia
city: Boca Raton
country: United States
facility: Site reference ID 231
state: Florida
city: Boca Raton
country: United States
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state: Florida
city: Clearwater
country: United States
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city: DeLand
country: United States
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city: Fort Lauderdale
country: United States
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city: Hialeah
country: United States
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city: Hialeah
country: United States
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city: Jacksonville
country: United States
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state: Florida
city: Loxahatchee Groves
country: United States
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state: Florida
city: Miami Lakes
country: United States
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state: Florida
city: Miami Lakes
country: United States
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state: Florida
city: Miami Springs
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
country: United States
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city: Miramar
country: United States
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city: New Port Richey
country: United States
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city: Orlando
country: United States
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state: Florida
city: Orlando
country: United States
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city: Saint Petersburg
country: United States
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state: Florida
city: Tampa
country: United States
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state: Florida
city: Columbus
country: United States
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state: Georgia
city: Norcross
country: United States
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state: Georgia
city: Norcross
country: United States
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state: Georgia
city: Sandy Springs
country: United States
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state: Georgia
city: Idaho Falls
country: United States
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state: Idaho
city: Meridian
country: United States
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state: Idaho
city: Champaign
country: United States
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state: Illinois
city: Oak Brook
country: United States
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state: Illinois
city: Shawnee Mission
country: United States
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state: Kansas
city: Wichita
country: United States
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state: Kansas
city: Lake Charles
country: United States
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state: Louisiana
city: Marrero
country: United States
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state: Louisiana
city: Frederick
country: United States
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state: Maryland
city: Silver Spring
country: United States
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state: Maryland
city: Towson
country: United States
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state: Maryland
city: Fall River
country: United States
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state: Massachusetts
city: Fall River
country: United States
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state: Massachusetts
city: Bay City
country: United States
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state: Michigan
city: Detroit
country: United States
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state: Michigan
city: Saginaw
country: United States
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state: Michigan
city: Saginaw
country: United States
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state: Michigan
city: Missoula
country: United States
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state: Montana
city: Las Vegas
country: United States
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state: Nevada
city: Lawrenceville
country: United States
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state: New Jersey
city: Brooklyn
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Port Jefferson
country: United States
facility: Site reference ID 208
state: New York
city: Staten Island
country: United States
facility: Site reference ID 133
state: New York
city: Greensboro
country: United States
facility: Site reference ID 104
state: North Carolina
city: Morehead City
country: United States
facility: Site reference ID 131
state: North Carolina
city: Raleigh
country: United States
facility: Site reference ID 102
state: North Carolina
city: Southern Pines
country: United States
facility: Site reference ID 187
state: North Carolina
city: Winston-Salem
country: United States
facility: Site reference ID 119
state: North Carolina
city: Cincinnati
country: United States
facility: Site reference ID 186
state: Ohio
city: Cleveland
country: United States
facility: Site reference ID 164
state: Ohio
city: Fairfield
country: United States
facility: Site reference ID 230
state: Ohio
city: Franklin
country: United States
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state: Ohio
city: Bryn Mawr
country: United States
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state: Pennsylvania
city: Hershey
country: United States
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state: Pennsylvania
city: Indiana
country: United States
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state: Pennsylvania
city: Jenkintown
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site reference ID 210
state: Pennsylvania
city: Smithfield
country: United States
facility: Site reference ID 148
state: Pennsylvania
city: North Charleston
country: United States
facility: Site reference ID 351
state: South Carolina
city: Spartanburg
country: United States
facility: Site reference ID 358
state: South Carolina
city: Chattanooga
country: United States
facility: Site reference ID 159
state: Tennessee
city: Knoxville
country: United States
facility: Site reference ID 235
state: Tennessee
city: Memphis
country: United States
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state: Tennessee
city: Memphis
country: United States
facility: Site reference ID 180
state: Tennessee
city: Austin
country: United States
facility: Site reference ID 238
state: Texas
city: Austin
country: United States
facility: Site reference ID 155
state: Texas
city: Beaumont
country: United States
facility: Site reference ID 201
state: Texas
city: Corpus Christi
country: United States
facility: Site reference ID 247
state: Texas
city: Dallas
country: United States
facility: Site reference ID 183
state: Texas
city: Dallas
country: United States
facility: Site reference ID 216
state: Texas
city: Dallas
country: United States
facility: Site reference ID 200
state: Texas
city: Fort Worth
country: United States
facility: Site reference ID 250
state: Texas
city: Fort Worth
country: United States
facility: Site reference ID 244
state: Texas
city: Frisco
country: United States
facility: Site reference ID 115
state: Texas
city: Houston
country: United States
facility: Site reference ID 157
state: Texas
city: Houston
country: United States
facility: Site reference ID 120
state: Texas
city: Houston
country: United States
facility: Site reference ID 219
state: Texas
city: Houston
country: United States
facility: Site reference ID 217
state: Texas
city: Pasadena
country: United States
facility: Site reference ID 218
state: Texas
city: San Antonio
country: United States
facility: Site reference ID 172
state: Texas
city: Webster
country: United States
facility: Site reference ID 128
state: Texas
city: West Jordan
country: United States
facility: Site reference ID 125
state: Utah
city: Norfolk
country: United States
facility: Site reference ID 103
state: Virginia
city: Norfolk
country: United States
facility: Site reference ID 171
state: Virginia
city: Richmond
country: United States
facility: Site reference ID 123
state: Virginia
city: Bellevue
country: United States
facility: Site reference ID 237
state: Washington
Study officials:
affiliation: Geneva
name: ObsEva SA
role: STUDY_DIRECTOR
References:
citation: 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.