Clinical trial NCT03070951: 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: 511
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: Chino
country: United States
facility: Site reference ID 905
state: California
city: Huntington Park
country: United States
facility: Site reference ID 918
state: California
city: San Diego
country: United States
facility: Site reference ID 902
state: California
city: Denver
country: United States
facility: Site reference ID 903
state: Colorado
city: Bradenton
country: United States
facility: Site reference ID 913
state: Florida
city: Orlando
country: United States
facility: Site reference ID 912
state: Florida
city: Augusta
country: United States
facility: Site reference ID 915
state: Georgia
city: Nampa
country: United States
facility: Site reference ID 924
state: Idaho
city: Covington
country: United States
facility: Site reference ID 926
state: Louisiana
city: Metairie
country: United States
facility: Site reference ID 927
state: Louisiana
city: Metairie
country: United States
facility: Site reference ID 900
state: Louisiana
city: Canton
country: United States
facility: Site reference ID 901
state: Michigan
city: Detroit
country: United States
facility: Site reference ID 932
state: Michigan
city: Jefferson City
country: United States
facility: Site reference ID 916
state: Missouri
city: Albuquerque
country: United States
facility: Site reference ID 930
state: New Mexico
city: West Seneca
country: United States
facility: Site reference ID 933
state: New York
city: Hamlet
country: United States
facility: Site reference ID 931
state: North Carolina
city: Westerville
country: United States
facility: Site reference ID 914
state: Ohio
city: Erie
country: United States
facility: Site reference ID 928
state: Pennsylvania
city: West Columbia
country: United States
facility: Site reference ID 919
state: South Carolina
city: Houston
country: United States
facility: Site reference ID 907
state: Texas
city: Salt Lake City
country: United States
facility: Site reference ID 911
state: Utah
city: Madison
country: United States
facility: Site reference ID 917
state: Wisconsin
city: Gabrovo
country: Bulgaria
facility: Site reference ID 265
city: Pleven
country: Bulgaria
facility: Site reference ID 255
city: Plovdiv
country: Bulgaria
facility: Site reference ID 258
city: Sliven
country: Bulgaria
facility: Site reference ID 266
city: Smolyan
country: Bulgaria
facility: Site reference ID 264
city: Sofia
country: Bulgaria
facility: Site reference ID 251
city: Sofia
country: Bulgaria
facility: Site reference ID 252
city: Sofia
country: Bulgaria
facility: Site reference ID 254
city: Sofia
country: Bulgaria
facility: Site reference ID 256
city: Sofia
country: Bulgaria
facility: Site reference ID 257
city: Sofia
country: Bulgaria
facility: Site reference ID 267
city: Praha
country: Czechia
facility: Site reference ID 281
city: Praha
country: Czechia
facility: Site reference ID 286
city: Praha
country: Czechia
facility: Site reference ID 287
city: Praha
country: Czechia
facility: Site reference ID 288
city: Písek
country: Czechia
facility: Site reference ID 283
city: Příbram
country: Czechia
facility: Site reference ID 284
city: Tábor
country: Czechia
facility: Site reference ID 289
city: Vsetín
country: Czechia
facility: Site reference ID 282
city: České Budějovice
country: Czechia
facility: Site reference ID 285
city: Baja
country: Hungary
facility: Site reference ID 315
city: Budapest
country: Hungary
facility: Site reference ID 303
city: Budapest
country: Hungary
facility: Site reference ID 307
city: Debrecen
country: Hungary
facility: Site reference ID 301
city: Debrecen
country: Hungary
facility: Site reference ID 308
city: Debrecen
country: Hungary
facility: Site reference ID 313
city: Kecskemét
country: Hungary
facility: Site reference ID 314
city: Kistarcsa
country: Hungary
facility: Site reference ID 304
city: Nyíregyháza
country: Hungary
facility: Site reference ID 306
city: Riga
country: Latvia
facility: Site reference ID 451
city: Riga
country: Latvia
facility: Site reference ID 452
city: Riga
country: Latvia
facility: Site reference ID 454
city: Kaunas
country: Lithuania
facility: Site reference ID 463
city: Vilnius
country: Lithuania
facility: Site reference ID 460
city: Vilnius
country: Lithuania
facility: Site reference ID 461
city: Vilnius
country: Lithuania
facility: Site reference ID 464
city: Białystok
country: Poland
facility: Site reference ID 502
city: Katowice
country: Poland
facility: Site reference ID 504
city: Katowice
country: Poland
facility: Site reference ID 509
city: Katowice
country: Poland
facility: Site reference ID 513
city: Katowice
country: Poland
facility: Site reference ID 514
city: Knurów
country: Poland
facility: Site reference ID 501
city: Lublin
country: Poland
facility: Site reference ID 506
city: Lublin
country: Poland
facility: Site reference ID 508
city: Lublin
country: Poland
facility: Site reference ID 511
city: Piaseczno
country: Poland
facility: Site reference ID 519
city: Poznań
country: Poland
facility: Site reference ID 518
city: Przemyśl
country: Poland
facility: Site reference ID 505
city: Szczecin
country: Poland
facility: Site reference ID 503
city: Warsaw
country: Poland
facility: Site reference ID 507
city: Łódź
country: Poland
facility: Site reference ID 510
city: Łódź
country: Poland
facility: Site reference ID 517
city: Świdnik
country: Poland
facility: Site reference ID 512
city: Braşov
country: Romania
facility: Site reference ID 606
city: Bucuresti
country: Romania
facility: Site reference ID 601
city: Bucuresti
country: Romania
facility: Site reference ID 603
city: Bucuresti
country: Romania
facility: Site reference ID 604
city: Târgu-Mureş
country: Romania
facility: Site reference ID 605
city: Chernivtsi
country: Ukraine
facility: Site reference ID 813
city: Ivano-Frankivs'k
country: Ukraine
facility: Site reference ID 801
city: Kharkiv
country: Ukraine
facility: Site reference ID 814
city: Kyiv
country: Ukraine
facility: Site reference ID 802
city: Kyiv
country: Ukraine
facility: Site reference ID 803
city: Kyiv
country: Ukraine
facility: Site reference ID 805
city: Kyiv
country: Ukraine
facility: Site reference ID 806
city: Kyiv
country: Ukraine
facility: Site reference ID 807
city: L'viv
country: Ukraine
facility: Site reference ID 804
city: Odesa
country: Ukraine
facility: Site reference ID 811
city: Ternopil'
country: Ukraine
facility: Site reference ID 808
city: Vinnytsia
country: Ukraine
facility: Site reference ID 817
city: Zaporizhzhya
country: Ukraine
facility: Site reference ID 812
city: Zaporizhzhya
country: Ukraine
facility: Site reference ID 815
city: Zaporizhzhya
country: Ukraine
facility: Site reference ID 816
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.