Clinical trial NCT00317148: Effect of Dehydroepiandrosterone (DHEA) on Hot Flashes in Postmenopausal Women
Official title: Phase II-III Placebo-Controlled, Study to Evaluate the Effects of DHEA on Vasomotor Symptoms (Hot Flashes) in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hot Flashes
Keywords: Hot Flashes
Menopause
Quality of Life
Hot flushes
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2006-04-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: 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
Other outcomes:
Locations:
city: Sainte-Foy
country: Canada
facility: Clinique des Traitements Hormonaux
state: Quebec
Study officials:
affiliation: CHUL Research Center
name: Leonello Cusan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHUL Research Director
name: Fernand Labrie, MD, PhD
role: STUDY_DIRECTOR
References:
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citation: Labrie F, Belanger A, Cusan L, Gomez JL, Candas B. Marked decline in serum concentrations of adrenal C19 sex steroid precursors and conjugated androgen metabolites during aging. J Clin Endocrinol Metab. 1997 Aug;82(8):2396-402. doi: 10.1210/jcem.82.8.4160.
citation: Labrie F, Diamond P, Cusan L, Gomez JL, Belanger A, Candas B. Effect of 12-month dehydroepiandrosterone replacement therapy on bone, vagina, and endometrium in postmenopausal women. J Clin Endocrinol Metab. 1997 Oct;82(10):3498-505. doi: 10.1210/jcem.82.10.4306.
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