Clinical Trial: A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

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

Official Title: A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.

Brief Summary: This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.

Detailed Summary: No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study
Sponsor: Abbott

Current Primary Outcome:

  • Percent change from baseline in uterine volume and volume of the largest fibroid. [ Time Frame: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6. ]
  • Duration of amenorrhea [ Time Frame: Day 1 to 1st post treatment menses ]


Original Primary Outcome: Percent change from baseline in uterine volume and volume of the largest fibroid.

Current Secondary Outcome:

  • Change from baseline in uterine size in gestational weeks. [ Time Frame: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6 ]
  • Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume. [ Time Frame: Week 12 and final visit ]
  • Percentage of days with bleeding. [ Time Frame: Day 1 through end of 1st post-treatment menses ]
  • Changes in hematologic and iron parameters. [ Time Frame: Baseline to each visit ]
  • Uterine fibroid symptom improvement. [ Time Frame: Baseline to each visit ]
  • Response to Global Efficacy Question regarding improvement in fibroid symptoms. [ Time Frame: Week 12 and Final Visit ]


Original Secondary Outcome: Duration of amenorrhea, percentage of bleeding days, and average daily bleeding score and frequency of menorrhagia, metorrhagia, dysmenorrhea, dyspareunia, etc.

Information By: Abbott

Dates:
Date Received: September 8, 2005
Date Started: May 2000
Date Completion:
Last Updated: May 27, 2008
Last Verified: May 2008