A Study to Evaluate the Safety and Effectiveness 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 safety and effectiveness of 3 asoprisnil doses 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 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

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

Conditions
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Amenorrhea, Postmenopause

Intervention / Treatment
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* Drug: Asoprisnil/Premarin
* Drug: Asoprisnil/Premarin
* Drug: Asoprisnil/Premarin
* Drug: Placebo and Premarin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women with an intact uterus Body mass index (BMI) between 18.0 - 33.0 Good general health Endometrial thickness ≤ 4 mm by TVU No history or suspected endometrial hyperplasia Negative urine pregnancy test Pap smear in last 6 months with no evidence of malignancy or pre-malignant changes Mammogram without suspicion of malignancy within last 6 months Endometrial biopsy with no evidence of pathologic changes within last 6 months Exclusion Criteria: Any abnormal lab result the study-doctor considers significant History of severe reaction to hormone therapy Receiving hormone therapy Currently using phytoestrogenic compounds, such as red clover, black cohosh (Promensil and Remifemin), dong quai, ginseng and soy isoflavones History or known or suspected cancer other than basal cell carcinoma Stenosis of the cervix History of reproductive endocrine disorder Washout requirement for hormonal therapy not met Ovarian mass Submucus or other symptomatic fibroid which would confound efficacy

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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Asoprisnil/Premarin<br>* Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks<br>|
| Experimental: 2<br> | Drug: Asoprisnil/Premarin<br>* Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks<br>|
| Experimental: 3<br> | Drug: Asoprisnil/Premarin<br>* Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks<br>|
| Placebo Comparator: 4<br> | Drug: Placebo and Premarin<br>* Placebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of endometrium by endometrial biopsy |  | Week 12 | 
| Change from baseline in endometrial thickness as assessed by ultrasound |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and amount of vaginal bleeding via patient diary. |  | Week 4, 8, and 12 | 
| Incidence of hot flushes |  | Week 4, 8, and 12 | 
| Presence or absence of endometrial hyperplasia. |  | Week 12 | 
| Response to global efficacy question regarding improvement in menopause symptoms. |  | Week 12 | 

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