Six Months DHEA Treatment in Female Adrenal Failure

Adrenal Insufficiency Clinical Trial

Official title:

Physiolocal Effects of 6 Months DHEA Substitutional Therapy in Female Adrenal Failure in a Randomised, Placebo Controlled and Overcrossed Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471900
• Other study ID #: 200110130
• Status: Completed
• Phase: N/A
• First received: May 9, 2007
• Last updated: May 9, 2007
• Start date: October 2001
• Est. completion date: February 2003

Study information

• Verified date: May 2007
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Female,

• Adrenal insuficiency,

• Stable and safe anticonception,

• Stable hydrocortison substituation treatment.

Exclusion Criteria:

• Neoplastic and thromboembolic disease,

• Diabetes mellitus.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adrenal Insufficiency

Intervention

Drug:
• dehydroepiandrosterone (DHEA)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life parameteres, cardiovascular parameters, bodycomposition, exercise parameters, hormonal and serological parameters, fuel metabolisme.		six months