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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00317148
First Posted: April 24, 2006
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval
  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: Placebos Drug: DHEA capsule Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 CHU de Quebec-Universite Laval:

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

Enrollment: 50
Actual Study Start Date: August 2005
Study Completion Date: December 2007
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo Drug: Placebos
Placebo capsule
Experimental: DHEA Drug: DHEA capsule
One capsule of DHEA

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317148


Locations
Canada, Quebec
Clinique des Traitements Hormonaux
Sainte-Foy, Quebec, Canada, G1V 4G2
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
Principal Investigator: Leonello Cusan, MD, PhD CHUL Research Center
Study Director: Fernand Labrie, MD, PhD CHUL Research Director
  More Information

Publications:
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.

Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT00317148     History of Changes
Other Study ID Numbers: ERC-205
First Submitted: April 20, 2006
First Posted: April 24, 2006
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHU de Quebec-Universite Laval:
Hot Flashes
Menopause
Quality of Life
Hot flushes

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs