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Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)

NCT03400956 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2022-06-30

Study results available
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Summary

The primary objective of this study was 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 were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids

Conditions

  • Uterine Fibroids

Interventions

DRUG

Vilaprisan (BAY1002670)

Orally, coated tablet 2 mg, once daily

DRUG

Placebo

Orally, coated tablet, 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
2018-01-24
Primary Completion
2019-03-23
Completion
2021-06-30
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Japan
  • Russia
  • Ukraine

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 NCT03400956 on ClinicalTrials.gov