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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03070899
Study type Interventional
Source ObsEva SA
Contact
Status Completed
Phase Phase 3
Start date April 20, 2017
Completion date April 12, 2021

See also
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