MedTrace Logo

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)

NCT03400943 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2023-05-03

Study results available
· View outcomes & findings →

Summary

The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.

The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.

Conditions

  • Uterine Fibroids

Interventions

DRUG

Vilaprisan (BAY1002670)

2 mg of Vilaprisan once daily up to 2 x 12 weeks

DRUG

Placebo

Matching placebo was administered to group B1 and B2.

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
2018-01-17
Primary Completion
2019-06-09
Completion
2022-04-06
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • China
  • Czechia
  • Israel
  • Malaysia
  • New Zealand
  • Singapore
  • South Africa

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 NCT03400943 on ClinicalTrials.gov