Clinical Trial: A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women

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

Official Title: A Phase II Pilot Study to Evaluate the Safety and Efficacy of J867 Administered With Estrogen to Postmenopausal Women

Brief Summary: The objective of this study is to determine the safety and effectiveness of 3 asoprisnil doses when administered to postmenopausal women with Premarin® 0.625 mg.

Detailed Summary: The objective of this study is to determine the safety and effectiveness of asoprisnil 5, 10, and 25 mg, compared to placebo, when administered to postmenopausal women, with Premarin® 0.625 mg, for 12 weeks. Pharmacodynamic effects to be assessed include bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events
Sponsor: Abbott

Current Primary Outcome:

  • Assessment of endometrium by endometrial biopsy [ Time Frame: Week 12 ]
  • Change from baseline in endometrial thickness as assessed by ultrasound [ Time Frame: Week 12 ]


Original Primary Outcome: The percent of subjects in each endometrial biopsy diagnostic category, mean change from baseline to final visit in endometrial thickness, and cumulative rates and incremental incidence rate of vaginal bleeding (bleeding, spotting, and amenorrhea).

Current Secondary Outcome:

  • Frequency and amount of vaginal bleeding via patient diary. [ Time Frame: Week 4, 8, and 12 ]
  • Incidence of hot flushes [ Time Frame: Week 4, 8, and 12 ]
  • Presence or absence of endometrial hyperplasia. [ Time Frame: Week 12 ]
  • Response to global efficacy question regarding improvement in menopause symptoms. [ Time Frame: Week 12 ]


Original Secondary Outcome: Secondary outcomes in this study will be percent of total bleeding days, mean number of moderate to severe hot flush, and mean weekly hot flush scores, etc.

Information By: Abbott

Dates:
Date Received: September 7, 2005
Date Started: September 2000
Date Completion:
Last Updated: May 27, 2008
Last Verified: May 2008