Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
- Conditions
- Heavy Menstrual BleedingUterine Fibroids
- Interventions
- Registration Number
- NCT03070951
- Lead Sponsor
- ObsEva SA
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 511
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OBE2109 dose 1 (100mg) + Placebo Add-back OBE2109 - OBE2109 dose 1 (100mg) + Placebo Add-back Placebo to match OBE2109 - OBE2109 dose 1 (100mg) + Placebo Add-back Placebo to match Add-back - OBE2109 dose 1 (100mg) + Add-back OBE2109 - OBE2109 dose 1 (100mg) + Add-back Placebo to match OBE2109 - OBE2109 dose 1 (100mg) + Add-back Add-back - OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back OBE2109 - OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back Placebo to match Add-back - OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back Add-back - OBE2109 dose 2 (200mg) + Add-back OBE2109 - OBE2109 dose 2 (200mg) + Add-back Add-back - Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back OBE2109 - Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back Placebo to match OBE2109 - Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back Placebo to match Add-back - Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back Add-back -
- Primary Outcome Measures
Name Time Method Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24 From baseline to Week 24 Assessed using the alkaline hematin method
- Secondary Outcome Measures
Name Time Method Amenorrhea Up to Week 52 Assessed using the alkaline hematin method
Time to reduced menstrual blood loss Up to Week 52 Assessed using the alkaline hematin method
Time to amenorrhea Up to Week 52 Number of days of uterine bleeding for the last 28-day interval prior to Week 24 last 28-day interval prior to Week 24 Assessed using the alkaline hematin method
Number of days of uterine bleeding for each 28-day interval Up to Week 52 Assessed using the alkaline hematin method
Trial Locations
- Locations (96)
Site reference ID 907
🇺🇸Houston, Texas, United States
Site reference ID 254
🇧🇬Sofia, Bulgaria
Site reference ID 505
🇵🇱Przemyśl, Poland
Site reference ID 464
🇱🇹Vilnius, Lithuania
Site reference ID 817
🇺🇦Vinnytsia, Ukraine
Site reference ID 266
🇧🇬Sliven, Bulgaria
Site reference ID 519
🇵🇱Piaseczno, Poland
Site reference ID 518
🇵🇱Poznań, Poland
Site reference ID 805
🇺🇦Kyiv, Ukraine
Site reference ID 251
🇧🇬Sofia, Bulgaria
Site reference ID 463
🇱🇹Kaunas, Lithuania
Site reference ID 507
🇵🇱Warsaw, Poland
Site reference ID 301
🇭🇺Debrecen, Hungary
Site reference ID 512
🇵🇱Świdnik, Poland
Site reference ID 807
🇺🇦Kyiv, Ukraine
Site reference ID 811
🇺🇦Odesa, Ukraine
Site reference ID 308
🇭🇺Debrecen, Hungary
Site reference ID 314
🇭🇺Kecskemét, Hungary
Site reference ID 451
🇱🇻Riga, Latvia
Site reference ID 303
🇭🇺Budapest, Hungary
Site reference ID 315
🇭🇺Baja, Hungary
Site reference ID 313
🇭🇺Debrecen, Hungary
Site reference ID 304
🇭🇺Kistarcsa, Hungary
Site reference ID 509
🇵🇱Katowice, Poland
Site reference ID 513
🇵🇱Katowice, Poland
Site reference ID 454
🇱🇻Riga, Latvia
Site reference ID 504
🇵🇱Katowice, Poland
Site reference ID 514
🇵🇱Katowice, Poland
Site reference ID 501
🇵🇱Knurów, Poland
Site reference ID 307
🇭🇺Budapest, Hungary
Site reference ID 911
🇺🇸Salt Lake City, Utah, United States
Site reference ID 932
🇺🇸Detroit, Michigan, United States
Site reference ID 804
🇺🇦L'viv, Ukraine
Site reference ID 517
🇵🇱Łódź, Poland
Site reference ID 905
🇺🇸Chino, California, United States
Site reference ID 918
🇺🇸Huntington Park, California, United States
Site reference ID 902
🇺🇸San Diego, California, United States
Site reference ID 903
🇺🇸Denver, Colorado, United States
Site reference ID 913
🇺🇸Bradenton, Florida, United States
Site reference ID 915
🇺🇸Augusta, Georgia, United States
Site reference ID 924
🇺🇸Nampa, Idaho, United States
Site reference ID 927
🇺🇸Metairie, Louisiana, United States
Site reference ID 900
🇺🇸Metairie, Louisiana, United States
Site reference ID 916
🇺🇸Jefferson City, Missouri, United States
Site reference ID 265
🇧🇬Gabrovo, Bulgaria
Site reference ID 901
🇺🇸Canton, Michigan, United States
Site reference ID 931
🇺🇸Hamlet, North Carolina, United States
Site reference ID 933
🇺🇸West Seneca, New York, United States
Site reference ID 919
🇺🇸West Columbia, South Carolina, United States
Site reference ID 914
🇺🇸Westerville, Ohio, United States
Site reference ID 255
🇧🇬Pleven, Bulgaria
Site reference ID 258
🇧🇬Plovdiv, Bulgaria
Site reference ID 264
🇧🇬Smolyan, Bulgaria
Site reference ID 252
🇧🇬Sofia, Bulgaria
Site reference ID 287
🇨🇿Praha, Czechia
Site reference ID 256
🇧🇬Sofia, Bulgaria
Site reference ID 257
🇧🇬Sofia, Bulgaria
Site reference ID 286
🇨🇿Praha, Czechia
Site reference ID 267
🇧🇬Sofia, Bulgaria
Site reference ID 281
🇨🇿Praha, Czechia
Site reference ID 288
🇨🇿Praha, Czechia
Site reference ID 283
🇨🇿Písek, Czechia
Site reference ID 284
🇨🇿Příbram, Czechia
Site reference ID 282
🇨🇿Vsetín, Czechia
Site reference ID 289
🇨🇿Tábor, Czechia
Site reference ID 285
🇨🇿České Budějovice, Czechia
Site reference ID 306
🇭🇺Nyíregyháza, Hungary
Site reference ID 452
🇱🇻Riga, Latvia
Site reference ID 460
🇱🇹Vilnius, Lithuania
Site reference ID 461
🇱🇹Vilnius, Lithuania
Site reference ID 511
🇵🇱Lublin, Poland
Site reference ID 502
🇵🇱Białystok, Poland
Site reference ID 503
🇵🇱Szczecin, Poland
Site reference ID 506
🇵🇱Lublin, Poland
Site reference ID 508
🇵🇱Lublin, Poland
Site reference ID 510
🇵🇱Łódź, Poland
Site reference ID 606
🇷🇴Braşov, Romania
Site reference ID 601
🇷🇴Bucuresti, Romania
Site reference ID 603
🇷🇴Bucuresti, Romania
Site reference ID 605
🇷🇴Târgu-Mureş, Romania
Site reference ID 604
🇷🇴Bucuresti, Romania
Site reference ID 813
🇺🇦Chernivtsi, Ukraine
Site reference ID 814
🇺🇦Kharkiv, Ukraine
Site reference ID 801
🇺🇦Ivano-Frankivs'k, Ukraine
Site reference ID 802
🇺🇦Kyiv, Ukraine
Site reference ID 803
🇺🇦Kyiv, Ukraine
Site reference ID 806
🇺🇦Kyiv, Ukraine
Site reference ID 808
🇺🇦Ternopil', Ukraine
Site reference ID 812
🇺🇦Zaporizhzhya, Ukraine
Site reference ID 815
🇺🇦Zaporizhzhya, Ukraine
Site reference ID 816
🇺🇦Zaporizhzhya, Ukraine
Site reference ID 928
🇺🇸Erie, Pennsylvania, United States
Site reference ID 926
🇺🇸Covington, Louisiana, United States
Site reference ID 912
🇺🇸Orlando, Florida, United States
Site reference ID 930
🇺🇸Albuquerque, New Mexico, United States
Site reference ID 917
🇺🇸Madison, Wisconsin, United States