Effect of Dehydroepiandrosterone (DHEA) on Hot Flashes in Postmenopausal Women - Full Text View

Sponsored by:	Centre hospitalier universitaire de Québec
Information provided by:	Centre hospitalier universitaire de Québec
ClinicalTrials.gov Identifier:	NCT00317148

Purpose

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.

Condition	Intervention	Phase
Hot Flashes	Drug: Dehydroepiandrosterone	Phase II Phase III

Drug Information available for: Prasterone Dehydroepiandrosterone sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II-III Placebo-Controlled, Study to Evaluate the Effects of DHEA on Vasomotor Symptoms (Hot Flashes) in Postmenopausal Women

Further study details as provided by Centre hospitalier universitaire de Québec:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	50
Study Start Date:	August 2005
Estimated Study Completion Date:	September 2006

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

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317148

Locations

Canada, Quebec
Clinique des Traitements Hormonaux
Sainte-Foy, Quebec, Canada, G1V 4G2

Sponsors and Collaborators

Centre hospitalier universitaire de Québec

Investigators

Principal Investigator:	Leonello Cusan, MD, PhD	CHUL Research Center
Study Director:	Fernand Labrie, MD, PhD	CHUL Research Director

More Information

Publications:

Arlt W, Callies F, Koehler I, van Vlijmen JC, Fassnacht M, Strasburger CJ, Seibel MJ, Huebler D, Ernst M, Oettel M, Reincke M, Schulte HM, Allolio B. Dehydroepiandrosterone supplementation in healthy men with an age-related decline of dehydroepiandrosterone secretion. J Clin Endocrinol Metab. 2001 Oct;86(10):4686-92.

Baulieu EE. Neuroactive neurosteroids: dehydroepiandrosterone (DHEA) and DHEA sulphate. Acta Paediatr Suppl. 1999 Dec;88(433):78-80.

Belanger A, Candas B, Dupont A, Cusan L, Diamond P, Gomez JL, Labrie F. Changes in serum concentrations of conjugated and unconjugated steroids in 40- to 80-year-old men. J Clin Endocrinol Metab. 1994 Oct;79(4):1086-90.

Diamond P, Cusan L, Gomez JL, Belanger A, Labrie F. Metabolic effects of 12-month percutaneous dehydroepiandrosterone replacement therapy in postmenopausal women. J Endocrinol. 1996 Sep;150 Suppl:S43-50.

Flynn MA, Weaver-Osterholtz D, Sharpe-Timms KL, Allen S, Krause G. Dehydroepiandrosterone replacement in aging humans. J Clin Endocrinol Metab. 1999 May;84(5):1527-33.

Jedrzejuk D, Medras M, Milewicz A, Demissie M. Dehydroepiandrosterone replacement in healthy men with age-related decline of DHEA-S: effects on fat distribution, insulin sensitivity and lipid metabolism. Aging Male. 2003 Sep;6(3):151-6.

Labrie F. Intracrinology. Mol Cell Endocrinol. 1991 Jul;78(3):C113-8. Review.

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.

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.

Labrie F, Simard J, Luu-The V, Belanger A, Pelletier G, Morel Y, Mebarki F, Sanchez R, Durocher F, Turgeon C, Labrie Y, Rheaume E, Labrie C, Lachance Y. The 3B-hydroxysteroid dehydrogenase/isomerase gene family: lessons from type II 3B-HSD congenital deficiency.In: Signal Transduction in Testicular Cells. Ernst Schering Research Foundation Workshop. Hansson, V., Levy, F.O. and Tasken, K. (eds.), Berlin, Heidelberg, New York, Springer-Verlag, Vol. Suppl. 2:pp. 185-218, 1996.

Study ID Numbers:	ERC-205
Study First Received:	April 20, 2006
Last Updated:	September 6, 2006
ClinicalTrials.gov Identifier:	NCT00317148 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Centre hospitalier universitaire de Québec:

Hot Flashes
Menopause
Quality of Life

Study placed in the following topic categories:

Signs and Symptoms
Immunologic Factors
Adjuvants, Immunologic
Hot Flashes

Dehydroepiandrosterone
Quality of Life
Menopause

Additional relevant MeSH terms:

Signs and Symptoms
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

Hot Flashes
Dehydroepiandrosterone
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009