What side effects are associated with this type of intervention?

Common treatments for uterine fibroids include Selective Progesterone Receptor Modulators (SPRMs) like Vilaprisan, hormone therapies, and surgical options. SPRMs can cause side effects such as headaches, breast tenderness, and changes in menstrual bleeding patterns. Hormone therapies, including GnRH agonists, may lead to menopausal symptoms like hot flashes, mood swings, and decreased bone density. Surgical treatments, such as myomectomy, can result in risks associated with surgery, including infection, bleeding, and potential for fibroid recurrence.

What prior FDA approvals exist?

Selective Progesterone Receptor Modulators (SPRMs) like Vilaprisan are being studied for their efficacy in treating uterine fibroids. One notable SPRM that has been approved by the FDA for this condition is ulipristal acetate, marketed under the brand name Esmya. Ulipristal acetate has been shown to reduce fibroid size and control symptoms such as heavy menstrual bleeding. Other treatments for uterine fibroids include gonadotropin-releasing hormone (GnRH) agonists like leuprolide acetate, which also help in reducing fibroid size and managing symptoms. These treatments offer non-surgical options for managing uterine fibroids, providing relief from symptoms and improving quality of life for patients.

What other types of research exist?

Promising novel alternatives to Vilaprisan for uterine fibroids include Elagolix (an oral GnRH antagonist) and Relugolix (another oral GnRH antagonist). Both have shown efficacy in reducing fibroid size and associated symptoms. Additionally, Myfembree, a combination of Relugolix, estradiol, and norethindrone acetate, is FDA-approved and offers a comprehensive treatment option for managing uterine fibroids.

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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

Must not have

Any condition requiring immediate blood transfusion

Undiagnosed abnormal genital bleeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment phase: approximately 1 year, follow-up phase: up to 2 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing Vilaprisan, a medication for women with uterine fibroids. It aims to see if Vilaprisan can reduce fibroid size and symptoms by blocking hormones that make fibroids grow. Vilaprisan is a new and highly effective treatment developed for uterine fibroids and endometriosis.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need a blood transfusion right away.

Select...

I have experienced unexplained bleeding from my genital area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment phase: approximately 1 year, follow-up phase: up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Selective Progesterone Receptor Modulators (SPRMs) like Vilaprisan work by modulating the progesterone receptors in uterine fibroid tissues, which inhibits fibroid growth and reduces symptoms such as heavy menstrual bleeding and pelvic pain. This is significant for patients because progesterone is essential for the maintenance and growth of uterine fibroids. By targeting these receptors, SPRMs can effectively shrink fibroids and alleviate symptoms without the need for invasive surgery. Other hormone-based treatments, such as GnRH agonists, work by reducing estrogen and progesterone levels, leading to a temporary menopause-like state that also reduces fibroid size. However, SPRMs are often preferred due to fewer side effects and the ability to maintain a more normal hormonal balance.

The function role and synergic effect of syndecan-1 for mifepristone in uterine leiomyoma.Selective Progesterone Receptor Modulators-Mechanisms and Therapeutic Utility.Selective estrogen receptor modulator and selective progesterone receptor modulator: therapeutic efficacy in the treatment of uterine leiomyoma.