Effect of Dehydroepiandrosterone (DHEA) on Hot Flashes in Postmenopausal Women

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effect of daily oral intake of DHEA 50 mg for 4 months on reducing vasomotor symptoms (hot flashes) compared to placebo administration in postmenopausal women.

Detailed Description
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Humans, along with the other primates, are unique among animal species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone (DHEA) and especially its sulfate DHEA-S. The marked reduction in the formation of DHEA-S by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a situation that has been proposed to be associated with age-related diseases including skin atrophy, insulin resistance and obesity. Much attention has been given to the benefits of DHEA administered to postmenopausal women, especially on the bone, skin, vagina and well being after oral as well as percutaneous administration of the precursor steroid. This study proposes to study the effect of 50 mg oral DHEA capsules during a period of 4 months administered to postmenopausal women experiencing 50 or more moderate to severe hot flushes per week. Participants will be stratified by the number of hot flushes experienced per week. The two strata are: 50-70 or more than 70 hot flushes per week. During the study several biological and clinical parameters will be evaluated, as well as the reduction of the number of hot flashes and improvement of overall quality of life. Subjects will be evaluated at specific time intervals during the study for the above mentioned parameters as well as tolerability and adverse reactions.

Official Title
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Phase II-III Placebo-Controlled, Study to Evaluate the Effects of DHEA on Vasomotor Symptoms (Hot Flashes) in Postmenopausal Women

Conditions
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Hot Flashes

Intervention / Treatment
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* Drug: Placebos
* Drug: DHEA capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy postmenopausal women with 50 or more moderate to severe hot flushes. Women between 40 to 70 years of age. Exclusion Criteria: Body mass index (BMI) of 35 kg/m2 or more. Significant metabolic and endocrine diseases. Diagnosis of cancer. Use of steroids or drugs that interfere with the metabolism of estrogen. Use of any systemic estrogen, progestin, or DHEA in the eight weeks prior to randomization. Use of alternative therapies or natural products to treat postmenopausal symptoms in the four weeks prior to randomization. Palpable fibroids or uterine prolapse: Grade 2 or 3. Cigarette smoking

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br> | Drug: Placebos<br>* Placebo capsule<br>|
| Experimental: DHEA<br> | Drug: DHEA capsule<br>* One capsule of DHEA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of a diary to monitor the number and intensity of hot flashes as compared to placebo at screening, day 1, weeks 2, 4, 8, 12 and 16 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of safety as well as quality of life, psychological general well being, and sexual life by questionnaires at day 1, 2, 4, 8, 12 and 16 weeks of treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hot Flashes, Menopause, Quality of Life, Hot flushes