Effect of Dehydroepiandrosterone (DHEA) on Hot Flashes in Postmenopausal Women

NCT00317148 | Completed Phase 2

• 1 other identifier: ERC-205
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hot Flashes

Keywords

Hot Flashes; Menopause; Quality of Life; Hot flushes

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• 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

Study Arms (2)

Placebo

EXPERIMENTAL

Drug: Placebos

DHEA

EXPERIMENTAL

Drug: DHEA capsule

Interventions

Placebos DRUG

Placebo capsule

Placebo

DHEA capsule DRUG

One capsule of DHEA

DHEA

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy postmenopausal women with 50 or more moderate to severe hot flushes.
• Women between 40 to 70 years of age.

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

Clinique des Traitements Hormonaux

Sainte-Foy, Quebec, G1V 4G2, Canada

Location

Related Publications (10)

• 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.

  PMID: 11600526 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.

  PMID: 10626550 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.

  PMID: 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.

  PMID: 8943786 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.

  PMID: 10323374 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.

  PMID: 14628495 BACKGROUND

• Labrie F. Intracrinology. Mol Cell Endocrinol. 1991 Jul;78(3):C113-8. doi: 10.1016/0303-7207(91)90116-a.

  PMID: 1838082 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.

  PMID: 9253307 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.

  PMID: 9329392 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.

  BACKGROUND

MeSH Terms

Conditions

Hot Flashes

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Leonello Cusan, MD, PhD

  CHUL Research Center

  PRINCIPAL INVESTIGATOR

• Fernand Labrie, MD, PhD

  CHUL Research Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2006
• First Posted: April 24, 2006
• Study Start: August 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: December 1, 2007
• Last Updated: April 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)