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

  • STATUS
    Recruiting
  • participants needed
    156
  • sponsor
    Bayer
Updated on 8 May 2018
menorrhagia
leiomyoma
uterine fibroid
metrorrhagia
hyperplasia
endometrial hyperplasia
vilaprisan
bay1002670

Summary

The primary objective of this study is 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 are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.

Details
Condition UTERINE FIBROID
Treatment Placebo, Vilaprisan (BAY1002670)
Clinical Study IdentifierNCT03400956
SponsorBayer
Last Modified on8 May 2018

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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