Clinical Trial: Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Parallel-group, Double-blind Placebo-controlled and Open Label Active Controlled, Multi-center Study to Assess the Efficacy and Safety of Vilaprisan in Patients With Uterine

Brief Summary: The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with uterine fibroids compared to placebo and ulipristal. It is also aimed to evaluate the safety of vilaprisan in subjects with uterine fibroids. Further, data on population pharmacokinetic (PK)/ pharmacodynamic (PD) relationship for vilaprisan in subjects with uterine fibroids will be supplemented.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: Amenorrhea (yes/no) [ Time Frame: From day 7 to day 84 of treatment. ]

Defined as no scheduled or unscheduled bleeding/spotting after end of the initial bleeding episode until the end of the respective treatment period.


Original Primary Outcome: Amenorrhea (yes/no) [ Time Frame: From day 7 to day 84 of treatment. ]

Defined as no scheduled or unscheduled bleeding/spotting after end of the initial bleeding episode until the end of the respective treatment period


Current Secondary Outcome:

  • Number of bleeding days [ Time Frame: Up to 32 weeks ]
  • Time to onset of controlled bleeding [ Time Frame: Up to 28 weeks ]
  • Percent change in volume of largest fibroid from baseline to end of treatment. [ Time Frame: Baseline and up to 28 weeks ]
  • Endometrial histology [ Time Frame: Baseline and up to 40 weeks ]
    (Frequency of the following categories: benign endometrium, endometrial hyperplasia, malignant neoplasm)
  • Endometrial thickness measured by transvaginal ultrasound. [ Time Frame: Baseline and up to 40 weeks ]


Original Secondary Outcome:

  • Number of bleeding days [ Time Frame: Up to 32 weeks ]
  • Time to onset of controlled bleeding [ Time Frame: Up to 28 weeks ]
  • Percent change in volume of largest fibroid from baseline to end of treatment [ Time Frame: Baseline and up to 28 weeks ]
  • Endometrial histology [ Time Frame: Baseline and up to 40 weeks ]
    (Frequency of the following categories: benign endometrium, endometrial hyperplasia, malignant neoplasm)
  • Endometrial thickness measured by transvaginal ultrasound [ Time Frame: Baseline and up to 40 weeks ]


Information By: Bayer

Dates:
Date Received: May 22, 2015
Date Started: June 2015
Date Completion:
Last Updated: November 21, 2016
Last Verified: November 2016