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Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids (PRIMROSE 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03070951
Recruitment Status : Active, not recruiting
First Posted : March 6, 2017
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
ObsEva SA

Tracking Information
First Submitted Date  ICMJE February 17, 2017
First Posted Date  ICMJE March 6, 2017
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE May 23, 2017
Actual Primary Completion Date September 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24 [ Time Frame: From baseline to Week 24 ]
Assessed using the alkaline hematin method
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2019)
  • Time to reduced menstrual blood loss [ Time Frame: Up to Week 52 ]
    Assessed using the alkaline hematin method
  • Amenorrhea [ Time Frame: Up to Week 52 ]
    Assessed using the alkaline hematin method
  • Time to amenorrhea [ Time Frame: Up to Week 52 ]
  • Number of days of uterine bleeding for the last 28-day interval prior to Week 24 [ Time Frame: 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 [ Time Frame: Up to Week 52 ]
    Assessed using the alkaline hematin method
Original Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
  • Amenorrhea [ Time Frame: Up to Week 52 ]
    Assessed using the alkaline hematin method
  • Time to amenorrhea [ Time Frame: Up to Week 52 ]
  • Time to reduced menstrual blood loss [ Time Frame: Up to Week 52 ]
    Assessed using the alkaline hematin method
  • Number of days of uterine bleeding for each 28-day interval [ Time Frame: Up to Week 52 ]
    Assessed using the alkaline hematin method
Current Other Pre-specified Outcome Measures
 (submitted: July 24, 2020)
  • Bone Mineral Density (BMD) [ Time Frame: From baseline up to Week 76 ]
    Assessed by dual-energy X-ray absorptiometry (DXA) scan
  • Endometrial biopsy [ Time Frame: From baseline up to Week 52 ]
    Assessed by histology
  • Adverse events [ Time Frame: Up to Week 76 ]
    Frequency and severity of Treatment-Emergent Adverse Events
Original Other Pre-specified Outcome Measures
 (submitted: February 28, 2017)
  • Bone Mineral Density (BMD) [ Time Frame: From baseline up to Week 52 ]
    Assessed by dual-energy X-ray absorptiometry (DXA) scan
  • Endometrial biopsy [ Time Frame: From baseline up to Week 52 ]
    Assessed by histology
  • Adverse events [ Time Frame: Up to Week 52 ]
    Frequency and severity of Treatment-Emergent Adverse Events
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Uterine Fibroids
  • Heavy Menstrual Bleeding
Intervention  ICMJE
  • Drug: Placebo + Placebo Add-back
    Placebo tablets and Placebo Add-back for oral administration once daily
  • Drug: OBE2109 + Placebo Add-back
    OBE2109 tablets and Placebo Add-back for oral administration once daily
  • Drug: OBE2109 + Add-back
    OBE2109 tablets and Add-back for oral administration once daily
Study Arms  ICMJE
  • Experimental: OBE2109 dose 1 + Placebo Add-back
    Intervention: Drug: OBE2109 + Placebo Add-back
  • Experimental: OBE2109 dose 1 + Add-back
    Intervention: Drug: OBE2109 + Add-back
  • Experimental: OBE2109 dose 2 + Placebo Add-back
    Intervention: Drug: OBE2109 + Placebo Add-back
  • Experimental: OBE2109 dose 2 + Add-back
    Intervention: Drug: OBE2109 + Add-back
  • Placebo Comparator: Placebo + Placebo Add-back / OBE2109 dose 3 + Add-back
    Interventions:
    • Drug: Placebo + Placebo Add-back
    • Drug: OBE2109 + Add-back
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 26, 2019)
511
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2017)
500
Estimated Study Completion Date  ICMJE September 2020
Actual Primary Completion Date September 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Czechia,   Hungary,   Latvia,   Lithuania,   Poland,   Romania,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03070951
Other Study ID Numbers  ICMJE 16-OBE2109-009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ObsEva SA
Study Sponsor  ICMJE ObsEva SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ObsEva SA Geneva
PRS Account ObsEva SA
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP