Hot Flashes Clinical Trial
Official title:
Phase II-III Placebo-Controlled, Study to Evaluate the Effects of DHEA on Vasomotor Symptoms (Hot Flashes) in Postmenopausal Women
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.
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.
;
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