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Ovarian Contribution to Androgen Production in Adolescent Girls

7 Years
18 Years
Open (Enrolling)
Polycystic Ovary Syndrome, Obesity, Hyperandrogenism

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Trial Information

Ovarian Contribution to Androgen Production in Adolescent Girls

Inclusion Criteria:

- Girls age 7-18 years

- Normal weight (BMI 5-85%-ile for age) or overweight (>85%-ile)

- With or without signs of excess androgen

- 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:

- Patients currently enrolled in another research protocol will be excluded, except for
those enrolled in IRB-HSR12702/JCM022. This protocol is designed to allow subjects
enrolling in IRB-HSR12702/JCM022 to simultaneously participate in this companion

- Inability to comprehend what will be done during the study or why it will be done

- BMI-for-age < 5th percentile

- Weight < 27 kg if simultaneously participating in IRB-HSR12702/JCM022 due to blood
volume limits

- Obesity associated with a diagnosed genetic syndrome (e.g. Prader-Willi syndrome)

- Since the study involves looking at ovarian function, boys will be excluded.

- Positive pregnancy test or lactation. Subjects with a positive pregnancy test will
be informed of the result by the screening physician. Under Virginia law, parental
notification is not required for minors. However, the screening physician will
encourage them to tell their parent(s) and counsel them about the importance of
appropriate prenatal care and counseling. We will arrange follow-up for them at the
Teen Health Clinic at the University of Virginia or their primary care physician's
office in a timely manner.

- Abnormal laboratory studies will be confirmed by repeat testing to exclude laboratory

- Morning cortisol < 3 microgram/dL or history of Cushing syndrome or adrenal

- History of congenital adrenal hyperplasia or 17-hydroxyprogesterone > 300 ng/dL,
which suggests the possibility of congenital adrenal hyperplasia (if postmenarchal,
the 17-hydroxyprogesterone will be collected during the follicular phase, or ≥ 40
days since last menses if oligomenorrheic). NOTE: If a 17-hydroxyprogesterone >300
mg/dL is confirmed on repeat testing, an ACTH-stimulated 17-hydroxyprogesterone <1000
ng/dL will be required for study participation.

- Total testosterone > 150 ng/dL

- Previous diagnosis of diabetes, fasting glucose ≥126 mg/dL, or a hemoglobin A1c >6.5%

- Abnormal thyroid stimulating hormone (TSH) for age. Subjects with adequately treated
hypothyroidism, reflected by normal TSH values, will not be excluded.

- Abnormal prolactin. Mild elevations may be seen in overweight girls, and elevations
<1.5 times the upper limit of normal will be accepted in this group.

- Persistent hematocrit <36% and hemoglobin <12 g/dL. Subjects with a mildly low
hematocrit (33-36%) will be asked to take iron in the form of ferrous gluconate for
up to 60 days. Subjects weighing ≤ 36 kg will take one 300-325 mg tablet oral
ferrous gluconate daily (containing 36 mg elemental iron); subjects weighing >36 kg
will take two 300-325 mg tablets oral ferrous gluconate daily (containing 36 mg
elemental iron each). They will return to the CRU or alternate UVA clinical unit
after 30-60 days of iron therapy to have their hemoglobin or hematocrit rechecked and
will proceed with the remainder of the study if it is ≥12 g/dL or ≥36%, respectively.

- Persistent liver test abnormalities, with the exception that mild bilirubin
elevations will be accepted in the setting of known Gilbert's syndrome. Mild
elevations may be seen in overweight girls, so elevations <1.5 times the upper limit
of normal will be accepted in this group.

Type of Study:


Study Design:

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

Outcome Measure:

Assess baseline and stimulated ovarian hormone levels in response to recombinant human chorionic gonadotropin administration in normal weight and overweight girls across puberty

Outcome Time Frame:

24 hours after administration of human chorionic gonadotropin (r-hCG) administration

Safety Issue:


Principal Investigator

Christine Burt Solorzano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia Center for Research in Reproduction


United States: Institutional Review Board

Study ID:




Start Date:

December 2010

Completion Date:

Related Keywords:

  • Polycystic Ovary Syndrome
  • Obesity
  • Hyperandrogenism
  • Obesity
  • Polycystic Ovary Syndrome
  • Hyperandrogenism



University of Virginia Center for Research in Reproduction Charlottesville, Virginia  22902