Status:
UNKNOWN
Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, San Diego
Conditions:
Hyperandrogenemia
Polycystic Ovary Syndrome
Eligibility:
FEMALE
7-18 years
Phase:
NA
Brief Summary
Women with polycystic ovary syndrome (PCOS) often have irregular menstrual periods, too much facial and body hair, and weight gain. Women with PCOS also have a hard time becoming pregnant. Girls with ...
Detailed Description
We propose that the adrenal gland is the predominant source of the early morning rise in progesterone and testosterone which is more marked in early puberty. Specifically, we hypothesize that dexameth...
Eligibility Criteria
Inclusion
- Normal and obese (\>95th BMI%) females
- Weight of 24 kg or more
- Early to late puberty (expected age range 7-18)
- Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated LH, lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)
Exclusion
- Screening labs outside of age-appropriate normal range
- Hemoglobin \<12 mg/dL and hematocrit\<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still \<36%, they will be excluded.)
- Morning Cortisol \<5 g/dL
- 17-hydroxyprogesterone \>295 ng/dL
- Weight\<24 kg
- History of Cushing's syndrome or adrenal insufficiency
- Pregnant (self reported)
Key Trial Info
Start Date :
October 10 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT01421797
Start Date
October 10 2006
End Date
December 1 2024
Last Update
October 27 2023
Active Locations (1)
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1
University of Virginia Center for Research in Reproduction
Charlottesville, Virginia, United States, 22902