Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Uterine Fibroids

In brief

The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) 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

NCT03400956

Run by

Bayer

People needed

103

Starts

2018-01-24

Expected to finish

2021-06-30

Last updated by the study team

2022-06-30

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 more than 30 mm and less than 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 the 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 months since delivery, abortion, or lactation before start of treatment)
• Hypersensitivity to any ingredient of the study drug
• Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation)
• 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 (e.g. laxatives)
• Use of other treatments that might interfere with the conduct of the study or the interpretation of results
• Undiagnosed abnormal genital bleeding

Where it is running

• Diagnamics, Inc. — Encinitas, California, United States
• National Research Institute — Huntington Park, California, United States
• Grossmont Center for Clinical Research — La Mesa, California, United States
• West Coast OB/GYN Associates — La Mesa, California, United States
• National Research Institute — Panorama City, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Women's Medical Research Group, LLC — Clearwater, Florida, United States
• Vital Pharma Research — Hialeah, Florida, United States
• Solutions Through Advanced Research, Inc. — Jacksonville, Florida, United States
• Health Awareness, Inc. — Jupiter, Florida, United States
• South Florida Clinical Research Institute — Margate, Florida, United States
• Suncoast Research Group, LLC — Miami, Florida, United States
• Advanced Pharma CR, LLC — Miami, Florida, United States
• Genoma Research Group, Inc. — Miami, Florida, United States
• Florida Research Center, Inc. — Miami, Florida, United States
• Miami Dade Medical Research Institute, LLC — Miami, Florida, United States
• Vista Health Research — Miami, Florida, United States
• Palmetto Professional Research — Miami, Florida, United States
• Savin Medical Group LLC — Miami Lakes, Florida, United States
• A Premier Medical Research of Florida, LLC — Orange City, Florida, United States
• Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare — Orlando, Florida, United States
• Oviedo Medical Research, LLC — Oviedo, Florida, United States
• DMI Research — Pinellas Park, Florida, United States
• Clearview Medical Research, LLC — Canyon Country, California, United States

Full record on ClinicalTrials.gov

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