Understanding the effects of excess androgen in patients
Official title: Natural History Study of Patients With Excess Androgen
Run by National Institutes of Health Clinical Center (CC) · NCT00250159 · Data updated 2026-11-12
This study is trying to understand how too much androgen affects people with certain genetic conditions, like congenital adrenal hyperplasia and familial male-limited precocious puberty, by looking at their growth, hormone levels, and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 99 Years |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Status | Recruiting |
| Started | January 2, 2006 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT00250159 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include males aged 0-99 with known or suspected FMPP and patients of any age with known or suspected CAH.
✕Probably not a fit
Patients with isolated polycystic ovary syndrome or significant non-endocrine medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to gather and evaluate information from patients with genetic conditions that cause excess androgen, specifically focusing on congenital adrenal hyperplasia (CAH) and familial male-limited precocious puberty (FMPP). By collecting data on growth, hormonal levels, metabolic factors, and psychological characteristics, the study seeks to create a comprehensive phenotypic profile of these patients. The findings will help elucidate the effects of androgen excess and inform future therapeutic interventions.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of conditions associated with excess androgen, ultimately enhancing patient care.
How similar studies have gone: While this study builds on existing knowledge of androgen excess, it aims to provide a more comprehensive understanding, indicating a novel approach in this area.
Who can join: the full rules
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: 1. Males, ages 0 - 99 with known or suspected FMPP or 2. Patients (males and females, ages 0 - 99) with known or suspected (based on hormonal, clinical and/or genetic testing) CAH of any type. 3. Patients with excess androgen of unknown etiology or 4. Relatives of patients in this protocol. EXCLUSION CRITERIA: 1. 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. 2. Patients with significant non-endocrine medical conditions. 3. Females who are pregnant at the time of initial enrollment.
Where it's running
-
National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting -
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States Completed
Study contacts
- Principal investigator: Deborah P Merke, M.D. — Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study coordinator: Deborah P Merke, M.D.
- Email: dmerke@nih.gov
- Phone: (301) 496-0718
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.