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


N/A
7 Years
18 Years
Not Enrolling
Female
Hyperandrogenemia, Obesity, Polycystic Ovary Syndrome

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Trial Information

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


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 LH, lipids, testosterone, prolactin, DHEAS, E2,
glucose, and insulin and decreased FSH and/or 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration

Outcome Time Frame:

4 weeks after leuprolide

Safety Issue:

No

Principal Investigator

Christine M. Burt Solorzano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Institutional Review Board

Study ID:

CBS007

NCT ID:

NCT01422096

Start Date:

Completion Date:

Related Keywords:

  • Hyperandrogenemia
  • Obesity
  • Polycystic Ovary Syndrome
  • Obesity
  • Polycystic Ovary Syndrome
  • Overweight

Name

Location

University of Virginia Center for Research in ReproductionCharlottesville, Virginia  22902