Clinical Trial: A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.

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

Official Title: A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata

Brief Summary: This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.

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 long-term safety of asoprisnil 10 mg daily for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will be based on ultrasound and endometrial biopsy results, adverse events, and any changes from baseline laboratory values and vital signs.
Sponsor: Abbott

Current Primary Outcome:

  • Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144 [ Time Frame: Treatment months 3 and 6 and Post-treatment months 3 and 6 ]
  • Percentage of subjects that achieved amenorrhea. [ Time Frame: Treatment months 1-6 ]


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

Current Secondary Outcome:

  • Improvement in hematologic parameters. [ Time Frame: Treatment months 2,4,and 6 ]
  • Improvement in Uterine fibroid symptoms(menorrhagia, metrorrhagia, pelvic pressure, bloating, urinary disorders, pelvic pain, dysmenorrhea, dyspareunia) using a 4 point scale [ Time Frame: Treatment Months 1-6 ]
  • Change from baseline in uterine size in gestational weeks. [ Time Frame: Months 3 and 6 ]
  • Duration of amenorrhea. [ Time Frame: Start of previous study to first post-treatment menses. ]
  • Response to global efficacy question regarding improvement of fibroid symptoms. [ Time Frame: Month 6 ]
  • Mean change from baseline for endocrine determinations. [ Time Frame: Months 2,4 and 6 ]


Original Secondary Outcome: Duration of amenorrhea and hematologic, endocrine, and clinical parameters, etc.

Information By: Abbott

Dates:
Date Received: September 7, 2005
Date Started: April 2001
Date Completion:
Last Updated: March 3, 2009
Last Verified: May 2008