Effect of Dehydroepiandrosterone (DHEA) on Hot Flashes in... | NCT00317148

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

NCT00317148

Sponsor

CHU de Quebec-Universite Laval

Status

Completed

Last Update Posted

Apr 7, 2017Actual

Enrollment

50Actual

Phase

Phase 2Phase 3

Conditions

Hot Flashes

Interventions

Placebos
DHEA capsule

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005Actual

Primary Completion Date

Sep 2006Actual

Completion Date

Dec 2007Actual

First Submitted Date

Apr 20, 2006

First Submission Date that Met QC Criteria

Apr 20, 2006

First Posted Date

Apr 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2017

Last Update Posted Date

Apr 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Experimental		Drug: Placebos
DHEA	Experimental		Drug: DHEA capsule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebos	Drug	Placebo capsule	Placebo
DHEA capsule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leonello Cusan, MD, PhD	CHUL Research Center	Principal Investigator
Fernand Labrie, MD, PhD	CHUL Research Director	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique des Traitements Hormonaux		Sainte-Foy	Quebec	G1V 4G2	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11600526	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.
10626550

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473