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Phase III

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 6)

  • Study HIC#:2000021011
  • Last Updated:06/20/2018

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

  • Age18 years and older
  • GenderFemale only
  • Start Date04/17/2018
  • End Date12/30/2018

Trial Purpose and Description

The primary objective of this study is to evaluate the safety of vilaprisan in subjects with uterine fibroids in comparison to nonhormonal medical treatment in accordance with local standard of care. The secondary objective of this study is to evaluate the efficacy of vilaprisan in subjects with uterine fibroids in comparison to nonhormonal medical treatment in accordance with local standard of care. Other objectives of this study are to evaluate the variability in exposure in relation to the efficacy and safety for vilaprisan and to collect patientreported outcome (PRO) and clinician-reported outcome (ClinRO) data.

Eligibility Criteria

Inclusion Criteria:

  • 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

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
  • 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

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