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Selective Progesterone Receptor Modulator

Vilaprisan for Uterine Fibroids (ASTEROID 6 Trial)

Phase 3
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older
At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment phase: approximately 1 year, follow-up phase: up to 2 years
Awards & highlights

ASTEROID 6 Trial Summary

This trial found that Vilaprisan was more effective and had fewer side effects than the standard of care for uterine fibroids.

Who is the study for?
This trial is for women over 18 with uterine fibroids, experiencing symptoms like bleeding or pelvic pain. Participants must be in good health, have a recent ultrasound confirming fibroids, and use nonhormonal contraception during the study. Those pregnant, lactating less than 3 months ago, abusing substances, or with conditions that could affect the study can't join.Check my eligibility
What is being tested?
The trial is testing Vilaprisan's effectiveness and safety against standard care for uterine fibroids. It aims to see if Vilaprisan helps reduce symptoms better than usual treatments without causing more problems.See study design
What are the potential side effects?
Possible side effects of Vilaprisan may include hormonal changes (like altered menstrual cycles), gastrointestinal issues (nausea or abdominal pain), headaches, and potential liver-related issues. The exact side effects will be monitored throughout the trial.

ASTEROID 6 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I experience symptoms like bleeding or pelvic pain due to uterine fibroids.

ASTEROID 6 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment phase: approximately 1 year, follow-up phase: up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment phase: approximately 1 year, follow-up phase: up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine
Secondary outcome measures
Change From Baseline in Endometrial Thickness
Number of Bleeding Days
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
+1 more

ASTEROID 6 Trial Design

4Treatment groups
Experimental Treatment
Group I: B(Standard of care)Experimental Treatment1 Intervention
Standard of care as determined by the investigators, this could be watch & wait or non-hormonal medical treatment
Group II: A3(3/2 regimen)Experimental Treatment1 Intervention
2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break
Group III: A2(6/2 regimen)Experimental Treatment1 Intervention
2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break
Group IV: A1(3/1 regimen)Experimental Treatment1 Intervention
2.0 mg treatment of 12 weeks, each separated by 1 bleeding break
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vilaprisan (BAY1002670)
2018
Completed Phase 2
~270

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,237 Previous Clinical Trials
25,325,706 Total Patients Enrolled
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,260,667 Total Patients Enrolled

Media Library

Vilaprisan (Selective Progesterone Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT03194646 — Phase 3
Uterine Fibroids Research Study Groups: A1(3/1 regimen), A2(6/2 regimen), A3(3/2 regimen), B(Standard of care)
Uterine Fibroids Clinical Trial 2023: Vilaprisan Highlights & Side Effects. Trial Name: NCT03194646 — Phase 3
Vilaprisan (Selective Progesterone Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03194646 — Phase 3
Uterine Fibroids Patient Testimony for trial: Trial Name: NCT03194646 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the official position of the FDA on Vilaprisan (BAY1002670)?

"There is some clinical data to support the efficacy of Vilaprisan, as well as multiple rounds of data affirming its safety. As such, we have rated it a 3 on our Power scale."

Answered by AI

Is this the first time that Vilaprisan (BAY1002670) has been used in a clinical trial?

"The original clinical trial for vilaprisan (BAY1002670) was conducted in 2017 at Sapporo West Ladies Clinic. As of now, there have been 131 completed clinical trials. There is currently 1 live clinical trial, with many of these studies based in Atlanta, Georgia."

Answered by AI

In how many different medical centers is this experiment being conducted today?

"The principle medical research facilities for this trial are Atlanta Women's Research Institute, Inc. - Atlanta in Atlanta, Georgia, Discovery Clinical Trials - Dallas in Dallas, Texas, and Fellows Research Alliance - Savannah in Savannah, Florida. In addition, there are 100 other research sites."

Answered by AI

Have scientists attempted anything similar to this research before?

"Development for Vilaprisan (BAY1002670) began in 2017 with an initial clinical study conducted by Bayer. After the successful Phase 3 approval in 2017, there is only one active trial being sponsored by Bayer."

Answered by AI

How many people are being tested in this experiment?

"Unfortunately, this particular clinical study is not enrolling patients at the moment. The first posting was on June 30th, 2017 with the most recent update being October 27th, 2022. However, there are other trials recruiting patients right now. There are 47 studies seeking patients with leiomyoma and 1 trial for Vilaprisan (BAY1002670) currently recruiting participants."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Florida
New York
Other
How old are they?
18 - 65
What site did they apply to?
Women's Medical Research Group, LLC
Fellows Research Alliance
Wayne State University Physicians Group
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

Want to stop bleeding. resolve heavy bleed and better quality of life. I would like to find relief without surgical intervention.
PatientReceived 1 prior treatment
I’m hoping this clinical trial can give me some relief from the heavy bleeding.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What is the purpose of this study? What does the trial actually address? is there compensation and if so how much?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
2017. "Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03194646.
All > Uterine Fibroids > Fibroids
~164 spots leftby Apr 2025
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