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
Overview
- Phase
- Phase 3
- Intervention
- Placebo to match Add-back
- Conditions
- Uterine Fibroids
- Sponsor
- ObsEva SA
- Enrollment
- 511
- Locations
- 96
- Primary Endpoint
- Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Premenopausal woman at screening.
- •Body Mass Index ≥ 18 kg/m
- •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.
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.
Arms & Interventions
OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back
Intervention: Placebo to match Add-back
OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back
Intervention: OBE2109
OBE2109 dose 1 (100mg) + Placebo Add-back
Intervention: OBE2109
OBE2109 dose 1 (100mg) + Placebo Add-back
Intervention: Placebo to match OBE2109
OBE2109 dose 1 (100mg) + Placebo Add-back
Intervention: Placebo to match Add-back
OBE2109 dose 1 (100mg) + Add-back
Intervention: OBE2109
OBE2109 dose 1 (100mg) + Add-back
Intervention: Placebo to match OBE2109
OBE2109 dose 1 (100mg) + Add-back
Intervention: Add-back
OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back
Intervention: Add-back
OBE2109 dose 2 (200mg) + Add-back
Intervention: OBE2109
OBE2109 dose 2 (200mg) + Add-back
Intervention: Add-back
Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back
Intervention: OBE2109
Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back
Intervention: Placebo to match OBE2109
Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back
Intervention: Placebo to match Add-back
Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back
Intervention: Add-back
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Time to amenorrhea(Up to Week 52)
- Time to reduced menstrual blood loss(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)
- Number of days of uterine bleeding for each 28-day interval(Up to Week 52)
- Amenorrhea(Up to Week 52)