Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

Stopped early · Phase 3

Conditions studied: Uterine Fibroids

In brief

The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care

Key facts

Study ID

NCT03194646

Run by

Bayer

People needed

1272

Starts

2017-06-30

Expected to finish

2024-07-11

Last updated by the study team

2025-07-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older
• Diagnosis of uterine fibroid(s) documented by ultrasound at screening AND/OR during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence
• At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain
• Good general health
• Normal or clinically insignificant cervical smear
• An endometrial biopsy performed during the screening period, without significant histological disorder
• Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study

You may not qualify if…

• Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
• Hypersensitivity to any ingredient of the study drug
• Any condition requiring immediate blood transfusion
• Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
• Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
• Abuse of alcohol, drugs, or medicines (eg, laxatives)
• Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
• Undiagnosed abnormal genital bleeding

Where it is running

• Women's Health Alliance of Mobile — Mobile, Alabama, United States
• AMR - Mobile, AL — Mobile, Alabama, United States
• Visions Clinical Research - Tucson — Tucson, Arizona, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• University of Arkansas for Medical Sciences - Neurology — Little Rock, Arkansas, United States
• Diagnamics | Encinitas, CA — Encinitas, California, United States
• Grossmont Center for Clinical Research — La Mesa, California, United States
• M3 Wake Research San Diego - Alvarado — San Diego, California, United States
• Women's Health Care Research | San Diego, CA — San Diego, California, United States
• West Coast OB/GYN Associates — San Diego, California, United States
• Advanced Women's Health Institute | Denver Office, Greenwood Village, CO — Greenwood Village, Colorado, United States
• Physicians' Research Options, LLC | Red Rocks OBGYN — Lakewood, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Stamford Hospital — Stamford, Connecticut, United States
• IntimMedicine | Washington, DC — Washington D.C., District of Columbia, United States
• Helix Biomedics LLC | Boynton Beach, FL — Boynton Beach, Florida, United States
• Women's Medical Research Group, LLC — Clearwater, Florida, United States
• Doral Medical Research — Doral, Florida, United States
• M & O Clinical Research, LLC — Fort Lauderdale, Florida, United States
• Solutions Through Advanced Research, Inc. — Jacksonville, Florida, United States
• Axcess Medical Research, LLC — Loxahatchee Groves, Florida, United States
• Suncoast Clinical Research - Palm Harbor — Palm Harbor, Florida, United States
• ONCOVA Clinical Research, Inc. — Saint Cloud, Florida, United States
• Swor Women's Care — Sarasota, Florida, United States
• Central Research Associates | Birmingham, AL — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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