drugset / Trial / NCT00317148
Effect of Dehydroepiandrosterone (DHEA) on Hot Flashes in Postmenopausal Women
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2005-08
- Primary completion
- 2006-09
- Completion
- 2007-12
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background Labrie F. Intracrinology. Mol Cell Endocrinol. 1991 Jul;78(3):C113-8. doi: 10.1016/0303-7207(91)90116-a.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dehydroepiandrosterone | Other / unclassified | 50 mg | Oral |
Indications
No indication recorded.