Effect of Dehydroepiandrosterone (DHEA) on Hot Flashes in Postmenopausal Women
NCT ID: NCT00317148
Last Updated: 2017-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
50 participants
INTERVENTIONAL
2005-08-31
2007-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebos
Placebo capsule
DHEA
DHEA capsule
One capsule of DHEA
Interventions
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Placebos
Placebo capsule
DHEA capsule
One capsule of DHEA
Eligibility Criteria
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Inclusion Criteria
* Women between 40 to 70 years of age.
Exclusion Criteria
* 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
40 Years
70 Years
FEMALE
Yes
Sponsors
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CHU de Quebec-Universite Laval
OTHER
Responsible Party
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Principal Investigators
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Leonello Cusan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHUL Research Center
Fernand Labrie, MD, PhD
Role: STUDY_DIRECTOR
CHUL Research Director
Locations
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Clinique des Traitements Hormonaux
Sainte-Foy, Quebec, Canada
Countries
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References
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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. doi: 10.1210/jcem.86.10.7974.
Baulieu EE. Neuroactive neurosteroids: dehydroepiandrosterone (DHEA) and DHEA sulphate. Acta Paediatr Suppl. 1999 Dec;88(433):78-80. doi: 10.1111/j.1651-2227.1999.tb14408.x.
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. doi: 10.1210/jcem.79.4.7962278.
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. doi: 10.1210/jcem.84.5.5672.
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. doi: 10.1016/0303-7207(91)90116-a.
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.
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.
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.
Other Identifiers
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ERC-205
Identifier Type: -
Identifier Source: org_study_id
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