Official Title: “A Phase II Long-Term Extension Safety Study of J867 Administered With Estrogen to Postmenopausal Women”

The objective of this study is to determine the long-term safety of asoprisnil 10 mg when administered to postmenopausal women with Premarin® 0.625 mg

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study

Study Primary Completion Date: December 2001

The objective of this study is to determine the long-term safety of asoprisnil 10 mg (2-5mg tablets) when taken with Premarin® 0.625 mg, by postmenopausal women, for 6 months after an initial 12 weeks in Study M00-198. Pharmacodynamic effects to be assessed include uterine 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.

Intervention(s) in this Clinical Trial

• Drug: Asoprisnil/Premarin
  • 10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System.
  • Time Frame: Throughout Study
    Safety Issue?: Yes
• The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System
  • Time Frame: Months 3,6
    Safety Issue?: Yes
• Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound.
  • Time Frame: Months 3,6
    Safety Issue?: Yes

Secondary Measures

• Frequency and amount of vaginal bleeding assessed via daily diary.
  • Time Frame: Throughout study
    Safety Issue?: No
• Frequency and severity of hot flushes assessed via daily diary.
  • Time Frame: Throughout study
    Safety Issue?: No
• Mean change from baseline in endocrine determinations.
  • Time Frame: Months 2,4,and 6
    Safety Issue?: No
• Global efficacy question
  • Time Frame: Month 6
    Safety Issue?: No

Inclusion Criteria:

• Successful completion of study M00-198
• Continued good general health
• Negative urine pregnancy test

Exclusion Criteria:

• History of known or suspected cancer other than basal cell carcinoma in last 5 years
• History of reproductive endocrine disorder
• Submucous or other symptomatic fibroid which would confound efficacy
• Ovarian mass
• Ongoing treatment with an excluded medication
• Stenosis of the cervix
• Any abnormal lab result the study-doctor considers significant.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 48 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

Medical Director Study Chair Abbott  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00152295

Study ID Number: M01-280

ClinicalTrials.gov Identifier: NCT00152295

Health Authority: United States: Food and Drug Administration