NCT00471900

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2007

Completed
Last Updated

May 10, 2007

Status Verified

May 1, 2007

First QC Date

May 9, 2007

Last Update Submit

May 9, 2007

Conditions

Adrenal Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Quality of life parameteres, cardiovascular parameters, bodycomposition, exercise parameters, hormonal and serological parameters, fuel metabolisme.

    six months

Interventions

dehydroepiandrosterone (DHEA)DRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Neoplastic and thromboembolic disease,
  • Diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adrenal Insufficiency

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Jens S Christiansen, Professor

    Medical Dept. M, Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2007

First Posted

May 10, 2007

Study Start

October 1, 2001

Study Completion

February 1, 2003

Last Updated

May 10, 2007

Record last verified: 2007-05