Vilaprisan for Uterine Fibroids
(ASTEROID 6 Trial)

Recruiting in Palo Alto (17 mi)

+275 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bayer

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Bayer Study Director

Principal Investigator

Bayer

Eligibility Criteria

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.

Inclusion Criteria

Good general health

I am 18 years old or older.

Normal or clinically insignificant cervical smear

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Exclusion Criteria

Hypersensitivity to any ingredient of the study drug

I don't have conditions or take meds that affect how my body handles drugs.

Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)

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Treatment Details

Interventions

Vilaprisan (Selective Progesterone Receptor Modulator)

Trial OverviewThe 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.

Participant Groups

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