Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

Study Overview
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Brief Summary
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This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women

Official Title
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A Multi-Center, Double-Blind, Placebo-Controlled Comparison of Multiple Doses of Esterified Estrogens and Methyltestosterone, in Combination and Alone, in Relieving Vasomotor Symptoms in Postmenopausal Women

Conditions
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Hot Flushes, Menopause, Postmenopause

Intervention / Treatment
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* Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
* Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
* Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
* Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
* Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
* Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
* Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
* Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
* Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be able to communicate with the Investigator and study staff and be able to complete the required study procedures, Be a female of any race between the ages of 45-65 years, in generally good health, Be either naturally or surgically postmenopausal (with or without a uterus) Exclusion Criteria: Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins, History of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study

Ages Eligible for Study
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Minimum Age: 45 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)<br>* oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT<br>|
| Experimental: 2<br> | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)<br>* oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT<br>|
| Experimental: 3<br> | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)<br>* oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT<br>|
| Active Comparator: 4<br> | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)<br>* oral tablet, QD, 12 weeks, 0.30 EE<br>|
| Experimental: 5<br> | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)<br>* oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT<br>|
| Experimental: 6<br> | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)<br>* oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT<br>|
| Active Comparator: 7<br> | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)<br>* oral tablet, QD, 12 weeks, 0.45 EE<br>|
| Active Comparator: 8<br> | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)<br>* oral tablet, QD, 12 weeks, 0.60 MT<br>|
| Placebo Comparator: 9<br> | Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)<br>* oral tablet, QD, 12 weeks, Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4 |  | 4 weeks | 
| Mean change in frequency of moderate to severe VMS from baseline to Week 12 |  | 12 weeks | 
| Mean change in severity of moderate to severe VMS from baseline to Week 4 |  | 4 weeks | 
| Mean change in severity of moderate to severe VMS from baseline to Week 12 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of moderate to severe and all hot flushes at each week |  | 12 weeks | 
| Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome |  | 12 weeks | 
| Mean change from baseline to Week 12 in vaginal pH |  | 12 weeks | 
| Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells) |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hormone replacement therapy, hot flushes, postmenopause