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NCT03070899 Clinical Trial

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

Uterine Fibroids Clinical Trial

— PRIMROSE 1  

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 NCT03070899
Other study ID # 16-OBE2109-008
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 20, 2017
Est. completion date April 12, 2021

Study information
Verified date June 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 526
Est. completion date April 12, 2021
Est. primary completion date April 14, 2020
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
United States Site reference ID 211 Arcadia California
United States Site reference ID 155 Austin Texas
United States Site reference ID 238 Austin Texas
United States Site reference ID 100 Bay City Michigan
United States Site reference ID 201 Beaumont Texas
United States Site reference ID 237 Bellevue Washington
United States Site reference ID 192 Birmingham Alabama
United States Site reference ID 190 Boca Raton Florida
United States Site reference ID 231 Boca Raton Florida
United States Site reference ID 175 Brooklyn New York
United States Site reference ID 116 Bryn Mawr Pennsylvania
United States Site reference ID 184 Cerritos California
United States Site reference ID 174 Champaign Illinois
United States Site reference ID 159 Chattanooga Tennessee
United States Site reference ID 186 Cincinnati Ohio
United States Site reference ID 168 Clearwater Florida
United States Site reference ID 164 Cleveland Ohio
United States Site reference ID 163 Columbus Georgia
United States Site reference ID 247 Corpus Christi Texas
United States Site reference ID 183 Dallas Texas
United States Site reference ID 200 Dallas Texas
United States Site reference ID 216 Dallas Texas
United States Site reference ID 233 DeLand Florida
United States Site reference ID 144 Denver Colorado
United States Site reference ID 145 Detroit Michigan
United States Site reference ID 169 Dothan Alabama
United States Site reference ID 246 Englewood Colorado
United States Site reference ID 147 Escondido California
United States Site reference ID 230 Fairfield Ohio
United States Site reference ID 126 Fall River Massachusetts
United States Site reference ID 149 Fall River Massachusetts
United States Site reference ID 197 Fort Lauderdale Florida
United States Site reference ID 244 Fort Worth Texas
United States Site reference ID 250 Fort Worth Texas
United States Site reference ID 213 Franklin Ohio
United States Site reference ID 248 Frederick Maryland
United States Site reference ID 115 Frisco Texas
United States Site reference ID 104 Greensboro North Carolina
United States Site reference ID 195 Hershey Pennsylvania
United States Site reference ID 135 Hialeah Florida
United States Site reference ID 146 Hialeah Florida
United States Site reference ID 120 Houston Texas
United States Site reference ID 157 Houston Texas
United States Site reference ID 217 Houston Texas
United States Site reference ID 219 Houston Texas
United States Site reference ID 154 Huntington Park California
United States Site reference ID 359 Idaho Falls Idaho
United States Site reference ID 222 Indiana Pennsylvania
United States Site reference ID 191 Jacksonville Florida
United States Site reference ID 165 Jenkintown Pennsylvania
United States Site reference ID 235 Knoxville Tennessee
United States Site reference ID 176 Lake Charles Louisiana
United States Site reference ID 236 Las Vegas Nevada
United States Site reference ID 245 Lawrenceville New Jersey
United States Site reference ID 185 Los Angeles California
United States Site reference ID 204 Loxahatchee Groves Florida
United States Site reference ID 109 Marrero Louisiana
United States Site reference ID 180 Memphis Tennessee
United States Site reference ID 205 Memphis Tennessee
United States Site reference ID 352 Meridian Idaho
United States Site reference ID 106 Miami Florida
United States Site reference ID 110 Miami Florida
United States Site reference ID 127 Miami Florida
United States Site reference ID 137 Miami Florida
United States Site reference ID 142 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 138 Missoula Montana
United States Site reference ID 353 Mobile Alabama
United States Site reference ID 131 Morehead City North Carolina
United States Site reference ID 189 New Haven Connecticut
United States Site reference ID 124 New Port Richey Florida
United States Site reference ID 188 New York New York
United States Site reference ID 151 Norcross Georgia
United States Site reference ID 158 Norcross Georgia
United States Site reference ID 103 Norfolk Virginia
United States Site reference ID 171 Norfolk Virginia
United States Site reference ID 351 North Charleston South Carolina
United States Site reference ID 199 Northridge California
United States Site reference ID 182 Oak Brook Illinois
United States Site reference ID 140 Orlando Florida
United States Site reference ID 141 Orlando Florida
United States Site reference ID 111 Panorama City California
United States Site reference ID 218 Pasadena Texas
United States Site reference ID 242 Phoenix Arizona
United States Site reference ID 210 Pittsburgh Pennsylvania
United States Site reference ID 208 Port Jefferson New York
United States Site reference ID 102 Raleigh North Carolina
United States Site reference ID 123 Richmond Virginia
United States Site reference ID 166 Sacramento California
United States Site reference ID 170 Saginaw Michigan
United States Site reference ID 214 Saginaw Michigan
United States Site reference ID 207 Saint Petersburg Florida
United States Site reference ID 172 San Antonio Texas
United States Site reference ID 101 San Diego California
United States Site reference ID 150 Sandy Springs Georgia
United States Site reference ID 178 Shawnee Mission Kansas
United States Site reference ID 226 Silver Spring Maryland
United States Site reference ID 148 Smithfield Pennsylvania
United States Site reference ID 187 Southern Pines North Carolina
United States Site reference ID 358 Spartanburg South Carolina
United States Site reference ID 133 Staten Island New York
United States Site reference ID 113 Tampa Florida
United States Site reference ID 234 Thornton Colorado
United States Site reference ID 228 Towson Maryland
United States Site reference ID 355 Tucson Arizona
United States Site reference ID 239 Upland California
United States Site reference ID 232 Vestavia Hills Alabama
United States Site reference ID 105 Washington District of Columbia
United States Site reference ID 128 Webster Texas
United States Site reference ID 125 West Jordan Utah
United States Site reference ID 112 Westminster California
United States Site reference ID 354 Wichita Kansas
United States Site reference ID 119 Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
ObsEva SA

Country where clinical trial is conducted

United States, 

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
Terminated NCT01555073 - Preemptive Analgesia Following Uterine Artery Embolization Phase 4
Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
Completed NCT01229826 - Magnetic Resonance Elastography (MRE) of Uterine Fibroids N/A