Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess

Conditions:Ovarian Cancer, Obesity Weight Loss, Women's Studies, Endocrine
Therapuetic Areas:Endocrinology, Oncology, Reproductive
Age Range:7 - 18
Start Date:June 1, 2018
End Date:July 17, 2018

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Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS007)

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 that one dose of depot leuprolide agonist administration will
improve androgen levels in girls with ovarian androgen overproduction. Specifically, this
intervention will improve androgen levels after ovarian stimulation testing with recombinant
human chorionic gonadotropin (rhCG).

Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
Charlottesville, Virginia 22902
Principal Investigator: Christine M. Burt Solorzano, MD
Phone: 434-243-6911
Charlottesville, VA
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