A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopause
Intervention: Asoprisnil/Premarin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s):
Medical Director, Study Chair, Affiliation: Abbott
Summary
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
Clinical Details
Official title: A Phase II Long-Term Extension Safety Study of J867 Administered With Estrogen to Postmenopausal Women
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Primary outcome: The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System.The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound.
Secondary outcome: Frequency and amount of vaginal bleeding assessed via daily diary.Frequency and severity of hot flushes assessed via daily diary. Mean change from baseline in endocrine determinations. Global efficacy question
Detailed description:
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.
Eligibility
Minimum age: 48 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: April 2001
Ending date: December 2001
Last updated: May 27, 2008
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