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Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency

NCT ID: NCT00575341

Last Updated: 2007-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Adrenal Insufficiency

Keywords

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Central Adrenal Insufficiency DHEA Pubes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

substitution of DHEA-hormone, oral, once daily

Group Type ACTIVE_COMPARATOR

Dehydroepiandrosterone

Intervention Type DRUG

25 mg DHEA, oral, once daily

2

substitution of placebo, oral, once daily

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo, oral, once daily

Interventions

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Dehydroepiandrosterone

25 mg DHEA, oral, once daily

Intervention Type DRUG

placebo

placebo, oral, once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

26 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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University-Children's Hospital Tuebingen, Pediatric Endocrinology

Principal Investigators

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Gerhard Binder, PD Dr. med.

Role: STUDY_DIRECTOR

Children´s Hospital Tuebingen

Locations

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Universitaere Kinderklinik

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Universitaetsklinik für Kinderheilkunde und Jugendmedizin

Tübingen, Baden-Wurttemberg, Germany

Site Status

Universitaetskinik für Kinder und Jugendliche

Erlangen, Bavaria, Germany

Site Status

Universitaetsklinik und Poliklinik für Kinder und Jungendliche

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

References

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Miller KK, Sesmilo G, Schiller A, Schoenfeld D, Burton S, Klibanski A. Androgen deficiency in women with hypopituitarism. J Clin Endocrinol Metab. 2001 Feb;86(2):561-7. doi: 10.1210/jcem.86.2.7246.

Reference Type BACKGROUND
PMID: 11158009 (View on PubMed)

Young J, Couzinet B, Nahoul K, Brailly S, Chanson P, Baulieu EE, Schaison G. Panhypopituitarism as a model to study the metabolism of dehydroepiandrosterone (DHEA) in humans. J Clin Endocrinol Metab. 1997 Aug;82(8):2578-85. doi: 10.1210/jcem.82.8.4157.

Reference Type BACKGROUND
PMID: 9253337 (View on PubMed)

Arlt W, Callies F, van Vlijmen JC, Koehler I, Reincke M, Bidlingmaier M, Huebler D, Oettel M, Ernst M, Schulte HM, Allolio B. Dehydroepiandrosterone replacement in women with adrenal insufficiency. N Engl J Med. 1999 Sep 30;341(14):1013-20. doi: 10.1056/NEJM199909303411401.

Reference Type BACKGROUND
PMID: 10502590 (View on PubMed)

Hunt PJ, Gurnell EM, Huppert FA, Richards C, Prevost AT, Wass JA, Herbert J, Chatterjee VK. Improvement in mood and fatigue after dehydroepiandrosterone replacement in Addison's disease in a randomized, double blind trial. J Clin Endocrinol Metab. 2000 Dec;85(12):4650-6. doi: 10.1210/jcem.85.12.7022.

Reference Type BACKGROUND
PMID: 11134123 (View on PubMed)

Johannsson G, Burman P, Wiren L, Engstrom BE, Nilsson AG, Ottosson M, Jonsson B, Bengtsson BA, Karlsson FA. Low dose dehydroepiandrosterone affects behavior in hypopituitary androgen-deficient women: a placebo-controlled trial. J Clin Endocrinol Metab. 2002 May;87(5):2046-52. doi: 10.1210/jcem.87.5.8494.

Reference Type BACKGROUND
PMID: 11994339 (View on PubMed)

Wit JM, Langenhorst VJ, Jansen M, Oostdijk WA, van Doorn J. Dehydroepiandrosterone sulfate treatment for atrichia pubis. Horm Res. 2001;56(3-4):134-9. doi: 10.1159/000048106.

Reference Type BACKGROUND
PMID: 11847477 (View on PubMed)

Other Identifiers

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Vorlagen-Nummer BfArM: 4020260

Identifier Type: -

Identifier Source: secondary_id

DHEA2000 - V18.03.2003

Identifier Type: -

Identifier Source: org_study_id