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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 25 February 2013
Main ID:  NCT00250159
Date of registration: 05/11/2005
Primary sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Public title: Natural History Study of Patients With Excess Androgen
Scientific title: Natural History Study of Patients With Excess Androgen
Date of first enrolment: October 2005
Target sample size: 1060
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00250159
Study type:  Observational
Study design:  N/A  
Countries of recruitment
United States
Contacts
Name:   For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Address: 
Telephone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Affiliation: 
Name:   Deborah P Merke, M.D.
Address: 
Telephone: (301) 496-0718
Email: dmerke@mail.cc.nih.gov
Affiliation: 
Name:   Deborah P Merke, M.D.
Address: 
Telephone:
Email:
Affiliation:  National Institutes of Health Clinical Center (CC)
Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

Males with known or suspected FMPP.

Patients with known or suspected CAH due to 21-hydroxylase deficiency, 11-hydroxylase
deficiency, or 3-beta-hydroxysteroid dehydrogenase deficiency. Classic and nonclassic
patients are eligible.

Patients with excess androgen of unknown etiology.

EXCLUSION CRITERIA:

Females with isolated polycystic ovary syndrome. If, following a diagnostic work-up, a
patient is determined to have PCOS as the only cause of her hyperandrogenism; she will no
longer be followed on this protocol.

Patients with significant nonendocrine medical conditions.



Age minimum: N/A
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Congenital Adrenal Hyperplasia (CAH)
Excess Androgen
Familial Male-Limited Precocious Puberty (FMPP)
Intervention(s)
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
06-CH-0011
060011
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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