Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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.

Official Title

A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids

Keywords

Leiomyoma Uterine fibroids Heavy menstrual bleeding Myofibroma Vilaprisan (BAY1002670) Vilaprisan (A1) Vilaprisan (A2)

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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 CAN'T join 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

Locations

  • Harbor - UCLA Medical Center
    Torrance California 90509-2910 United States
  • National Research Institute
    Los Angeles California 90057 United States
  • AVIVA Research
    Escondido California 92025 United States
  • Core Healthcare Group
    Cerritos California 90703 United States
  • California Center for Clinical Research
    Arcadia California 91007 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bayer
ID
NCT03400943
Phase
Phase 3 Research Study
Study Type
Interventional
Participants
At least 93 people participating
Last Updated