A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women
Phase 2
Completed
- Conditions
- Postmenopause
- Interventions
- Drug: Asoprisnil/Premarin
- Registration Number
- NCT00152295
- Lead Sponsor
- Abbott
- Brief 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 18
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Asoprisnil/Premarin -
- Primary Outcome Measures
Name Time Method The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System. Throughout Study The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System Months 3,6 Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound. Months 3,6
- Secondary Outcome Measures
Name Time Method Frequency and amount of vaginal bleeding assessed via daily diary. Throughout study Frequency and severity of hot flushes assessed via daily diary. Throughout study Mean change from baseline in endocrine determinations. Months 2,4,and 6 Global efficacy question Month 6