Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Uterine Fibroids

In brief

The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan 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.

Key facts

Study ID

NCT03400943

Run by

Bayer

People needed

93

Starts

2018-01-17

Expected to finish

2022-04-06

Last updated by the study team

2023-05-03

Who can join

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

You may qualify if…

• Women, 18 years or older in good General health
• Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter ≥ 30 mm and < 120 mm
• Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH) method
• An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology
• Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study

You may not qualify if…

• Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)
• Hypersensitivity to any ingredient of the study drug
• Any condition requiring immediate blood transfusion
• Laboratory values outside inclusion range before randomization and considered as clinically relevant.
• 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

• California Center for Clinical Research — Arcadia, California, United States
• Core Healthcare Group — Cerritos, California, United States
• AVIVA Research — Escondido, California, United States
• National Research Institute - Los Angeles — Los Angeles, California, United States
• Harbor - UCLA Medical Center — Torrance, California, United States
• Ideal Clinical Research — Aventura, Florida, United States
• South Florida Medical Research — Aventura, Florida, United States
• Helix Biomedics, LLC — Boynton Beach, Florida, United States
• Dr. Victoria Garcia & Associates, LLC Doral Medical Research — Doral, Florida, United States
• Sweet Hope Research Specialty, Inc. - Hialeah — Hialeah, Florida, United States
• Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare — Jacksonville, Florida, United States
• Altus Research — Lake Worth, Florida, United States
• Axcess Medical Research, LLC — Loxahatchee Groves, Florida, United States
• Ocean Blue Medical Research Center, Inc. — Miami Springs, Florida, United States
• Accelerated Enrollment Solutions a business of PPD — Orlando, Florida, United States
• Discovery Clinical Research — Plantation, Florida, United States
• ONCOVA Clinical Research, Inc. — Saint Cloud, Florida, United States
• Georgia Center For Women — Atlanta, Georgia, United States
• Agile Clinical Research Trials, LLC — Atlanta, Georgia, United States
• Atlanta Women's Research Institute, Inc. - Alpharetta — Atlanta, Georgia, United States
• Medisense, Inc. — Atlanta, Georgia, United States
• Paramount Research Solutions-College Park — College Park, Georgia, United States
• One Health Research Clinic — Norcross, Georgia, United States
• Fellows Research Alliance - Savannah — Savannah, Georgia, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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