Status:
WITHDRAWN
Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
Lead Sponsor:
University of Virginia
Conditions:
Hyperandrogenemia
Obesity
Eligibility:
FEMALE
7-18 years
Phase:
EARLY_PHASE1
Brief Summary
This study will test whether short-term suppression of ovarian function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize th...
Eligibility Criteria
Inclusion
- overweight (\>85th BMI%) females
- Early to late puberty (expected age range 7-18)
- Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage)
- 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 luteinizing hormone (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
- History of Cushing's syndrome or adrenal insufficiency
- Pregnant
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01422096
Start Date
June 1 2018
End Date
July 17 2018
Last Update
July 19 2018
Active Locations (1)
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1
University of Virginia Center for Research in Reproduction
Charlottesville, Virginia, United States, 22908