NCT03070951

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 511 (actual)
• Sponsor: ObsEva SA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Fibroids
• Heavy Menstrual Bleeding

Interventions

Type	Name	Description
DRUG	OBE2109	OBE2109 100mg tablets for oral administration once daily
DRUG	Placebo to match OBE2109	Placebo to match OBE2109 100mg tablets for oral administration once daily
DRUG	Placebo to match Add-back	Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
DRUG	Add-back	Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily

Timeline

• Start date: 2017-05-23
• Primary completion: 2019-09-16
• Completion: 2020-10-04
• First posted: 2017-03-06
• Last updated: 2021-03-05

Locations

96 sites across 9 countries: United States, Bulgaria, Czechia, Hungary, Latvia, Lithuania, Poland, Romania, Ukraine

Regulatory

• FDA-regulated drug study