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

  • STATUS
    Not Recruiting
  • participants needed
    500
  • sponsor
    ObsEva SA
Updated on 21 June 2021
body mass index
menorrhagia
leiomyoma
uterine fibroid
fibroids
obe2109

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.

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.

Details
Condition Menorrhagia, UTERINE FIBROID
Treatment Placebo + Placebo Add-back, OBE2109 + Placebo Add-back, OBE2109 + Add-back
Clinical Study IdentifierNCT03070899
SponsorObsEva SA
Last Modified on21 June 2021

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