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

NCT03070951 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2021-03-05

No results posted yet for this study

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.

Conditions

  • Uterine Fibroids
  • Heavy Menstrual Bleeding

Interventions

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

Sponsors & Collaborators

  • ObsEva SA

    lead INDUSTRY

Principal Investigators

  • ObsEva SA · Geneva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-23
Primary Completion
2019-09-16
Completion
2020-10-04
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03070951 on ClinicalTrials.gov