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NCT03070951 Clinical Trial

Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Uterine Fibroids Clinical Trial

— PRIMROSE 2  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03070951
Other study ID # 16-OBE2109-009
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 23, 2017
Est. completion date October 4, 2020

Study information
Verified date March 2021
Source ObsEva SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 511
Est. completion date October 4, 2020
Est. primary completion date September 16, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

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

Sponsors (1)
Lead Sponsor Collaborator
ObsEva SA

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Hungary,  Latvia,  Lithuania,  Poland,  Romania,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Other Bone Mineral Density (BMD) Assessed by dual-energy X-ray absorptiometry (DXA) scan From baseline up to Week 76
Other Endometrial biopsy Assessed by histology From baseline up to Week 52
Other Adverse events Frequency and severity of Treatment-Emergent Adverse Events Up to Week 76
Primary Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24 Assessed using the alkaline hematin method From baseline to Week 24
Secondary Time to reduced menstrual blood loss Assessed using the alkaline hematin method Up to Week 52
Secondary Amenorrhea Assessed using the alkaline hematin method Up to Week 52
Secondary Time to amenorrhea Up to Week 52
Secondary Number of days of uterine bleeding for the last 28-day interval prior to Week 24 Assessed using the alkaline hematin method last 28-day interval prior to Week 24
Secondary Number of days of uterine bleeding for each 28-day interval Assessed using the alkaline hematin method Up to Week 52
See also
  Status Clinical Trial Phase
Completed NCT01441635 - Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids Phase 2
Completed NCT00958334 - Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003 Phase 2
Withdrawn NCT04567589 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
Recruiting NCT05078307 - Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids N/A
Recruiting NCT02283502 - Clinical Test of the MRgHIFU System on Uterine Fibroids Phase 1
Completed NCT01739621 - Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200 Phase 2
Completed NCT01631903 - Extension of Study ZPV-200 Phase 2
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Not yet recruiting NCT03586947 - Association Between Vitamin D and the Risk of Uterine Fibroids N/A
Completed NCT02925494 - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Not yet recruiting NCT06055114 - Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Withdrawn NCT04567095 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Withdrawn NCT03699176 - Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Phase 3
Not yet recruiting NCT02884960 - Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization N/A
Completed NCT02472184 - Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy N/A
Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
Terminated NCT01555073 - Preemptive Analgesia Following Uterine Artery Embolization Phase 4
Completed NCT01229826 - Magnetic Resonance Elastography (MRE) of Uterine Fibroids N/A