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Trial record 79 of 236 for:    PRASTERONE

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

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.
 
ClinicalTrials.gov Identifier: NCT00317148
Recruitment Status : Completed
First Posted : April 24, 2006
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

Tracking Information
First Submitted Date  ICMJE April 20, 2006
First Posted Date  ICMJE April 24, 2006
Last Update Posted Date April 7, 2017
Actual Study Start Date  ICMJE August 2005
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2006)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00317148 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2006)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2006)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Dehydroepiandrosterone (DHEA) on Hot Flashes in Postmenopausal Women
Official Title  ICMJE Phase II-III Placebo-Controlled, Study to Evaluate the Effects of DHEA on Vasomotor Symptoms (Hot Flashes) in Postmenopausal Women
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hot Flashes
Intervention  ICMJE
  • Drug: Placebos
    Placebo capsule
  • Drug: DHEA capsule
    One capsule of DHEA
Study Arms  ICMJE
  • Experimental: Placebo
    Intervention: Drug: Placebos
  • Experimental: DHEA
    Intervention: Drug: DHEA capsule
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2006)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00317148
Other Study ID Numbers  ICMJE ERC-205
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CHU de Quebec-Universite Laval
Study Sponsor  ICMJE CHU de Quebec-Universite Laval
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leonello Cusan, MD, PhD CHUL Research Center
Study Director: Fernand Labrie, MD, PhD CHUL Research Director
PRS Account CHU de Quebec-Universite Laval
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP