DHEA2000: Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Completed

CT.gov ID

NCT00575341

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

5.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

30 adolescent girls and young women between 13 and 26 years with central adrenal insufficiency and a grand shortage of DHEA are recruit. The clinical trial is double-blind to show that the substitution of the hormone DHEA stimulates secondary hair growth, enhances well being and mood of the patients. It should also normalize the serum content of DHEA, aldosterone and testosterone.

Condition or Disease	Intervention/Treatment	Phase
Adrenal Insufficiency	Drug: Dehydroepiandrosterone Drug: placebo	Phase 3

Detailed Description

30 adolescent girls and young women between 13 and 26 years with central adrenal insufficiency and a grand shortage of DHEA are recruit. After randomization they either get DHEA or placebo for 12 months daily. The clinical trial is double-blind to show that the substitution of the hormone DHEA stimulates secondary hair growth, enhances well being and mood of the patients. It should also normalize the serum content of DHEA, aldosterone and testosterone.

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Dehydroepiandrosterone(DHEA) Substitution in Adolescent and Young Women With Central Adrenal Insufficiency. A Multicenter, Randomised Double Blind Trial

Study Start Date :

Oct 1, 2003

Actual Study Completion Date :

Apr 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 substitution of DHEA-hormone, oral, once daily	Drug: Dehydroepiandrosterone 25 mg DHEA, oral, once daily
Placebo Comparator: 2 substitution of placebo, oral, once daily	Drug: placebo placebo, oral, once daily

Arm

Intervention/Treatment

Active Comparator: 1

substitution of DHEA-hormone, oral, once daily

Drug: Dehydroepiandrosterone

25 mg DHEA, oral, once daily

Placebo Comparator: 2

substitution of placebo, oral, once daily

Drug: placebo

placebo, oral, once daily

Outcome Measures

Primary Outcome Measures

Increase of pubes as measured by tanner stage [one year]

Secondary Outcome Measures

enhancement in well being and mood by psychometric tests [one year]
normalization of the serum content of DHEA, androstanedione and testosterone [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 26 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

female gender
age between 13 and 26 Years
breast developement minimal Tanner stage 3
serum content of DHEAS less than 400 ng/ml
central hypocortisolism
2 additional pituitary hormon deficiencies (growth hormone, TSH, FSH, LH, prolactin, ADH)
no scheduled change of the auxilliary medication during the clinical trial

Exclusion Criteria:

initial diagnosis of a cerebral tumor less than one year
constitution after cerebral exposure with over 30 gray
craniopharyngioma with hypothalamic defect syndrome or relapse
blindness
mental retardation or psychiatric disorder
systemic disorder, diabetes mellitus, cardiovascular disease, liver disease requiring treatment
elevated liver enzyme levels
pregnancy
in case of no hypogonadism: no secure contraception

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitaere Kinderklinik	Heidelberg	Baden-Wuerttemberg	Germany	69120
2	Universitaetsklinik für Kinderheilkunde und Jugendmedizin	Tuebingen	Baden-Wuerttemberg	Germany	72076
3	Universitaetskinik für Kinder und Jugendliche	Erlangen	Bayern	Germany	91054
4	Universitaetsklinik und Poliklinik für Kinder und Jungendliche	Leipzig	Sachsen	Germany	04317