Six Months DHEA Treatment in Female Adrenal Failure | NCT00471900

Studies
Six Months DHEA Treatment in Female Adrenal Failure

NCT00471900

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

May 10, 2007Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Adrenal Insufficiency

Interventions

dehydroepiandrosterone (DHEA)

Countries

Not provided

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

May 2007

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

Oct 2001

Primary Completion Date

Not provided

Completion Date

Feb 2003Actual

First Submitted Date

May 9, 2007

First Submission Date that Met QC Criteria

May 9, 2007

First Posted Date

May 10, 2007Estimated

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

May 9, 2007

Last Update Posted Date

May 10, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

DHEA is an adrenal deriven androgen precourser. The impact of DHEA substitution therapy in adrenal failure is unknown as well as the physiologically effects of DHEA is unknown. Effects of physiologically DHEA substitution is investigated in the model of female adrenal failure.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Name	Type	Description	Arm Group Labels	Other Names
dehydroepiandrosterone (DHEA)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life parameteres, cardiovascular parameters, bodycomposition, exercise parameters, hormonal and serological parameters, fuel metabolisme.		six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female,
Adrenal insuficiency,
Stable and safe anticonception,
Stable hydrocortison substituation treatment.

Exclusion Criteria:

Neoplastic and thromboembolic disease,
Diabetes mellitus.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens S Christiansen, Professor	Medical Dept. M, Aarhus University Hospital	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000309	Adrenal Insufficiency

Ancestor Terms

ID	Term
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003687	Dehydroepiandrosterone

Ancestor Terms

ID	Term
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided