A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postmenopause

Intervention / Treatment
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* Drug: Asoprisnil/Premarin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 48 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Asoprisnil/Premarin<br>* 10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HRT, Postmenopausal, Amenorrhea, Hormone replacement therapy, asoprisnil, Estrogen Replacement Therapy, postmenopause