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Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

NCT03699176 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-01-18

No results posted yet for this study

Summary

The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.

Conditions

  • Uterine Fibroids

Interventions

DRUG

Vilaprisan (BAY1002670)

2 mg, once daily, oral

DRUG

Placebo

Once daily, oral

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-27
Primary Completion
2019-12-25
Completion
2019-12-25
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03699176 on ClinicalTrials.gov