Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Hemorrhage

Leiomyoma

Myofibroma

Uterine Hemorrhage

Menorrhagia

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Menstruation Disturbances

At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.

OBE2109 100mg tablets for oral administration once daily

OBE2109

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

Placebo to match OBE2109

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

Placebo to match Add-back

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

Add-back

ObsEva SA

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.

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

Assessed by dual-energy X-ray absorptiometry (DXA) scan

Frequency and severity of Treatment-Emergent Adverse Events

Assessed using the alkaline hematin method

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids	NCT03070899	Uterine Fibroid... Heavy Menstrual...	OBE2109 Placebo to matc... Placebo to matc... Add-back	18 Years -	ObsEva SA
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids	NCT03070951	Uterine Fibroid... Heavy Menstrual...	OBE2109 Placebo to matc... Placebo to matc... Add-back	18 Years -	ObsEva SA

Spots Global Cancer Trial Database for heavy uterine bleeding