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Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis

NCT03573336 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-05-04

Study results available
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Summary

The primary objective of this study was to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis.

The secondary objective of this study was to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis.

With the implementation of protocol version 4.0 dated 11-Dec-2018, no new subjects were enrolled. The objectives above cannot be reached as only limited data is available from subjects recruited before the temporary pause.

Conditions

  • Endometriosis

Interventions

DRUG

Vilaprisan (BAY1002670)

Intake orally, once daily

DRUG

Matching Placebo

Intake orally, once daily

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-04
Primary Completion
2019-03-18
Completion
2020-11-26
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada
  • Czechia
  • Finland
  • Italy
  • Japan
  • Poland

Study Locations

More Related Trials

Entities

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 NCT03573336 on ClinicalTrials.gov