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

ObsEva SA526 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

526

Conditions

Uterine Fibroids Heavy Menstrual Bleeding

Interventions

OBE2109DRUG

OBE2109 100mg tablets for oral administration once daily

Placebo to match OBE2109DRUG

Placebo to match OBE2109 100mg tablets for oral administration once daily

Placebo to match Add-backDRUG

Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.