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Ovarian Contribution to Androgen Production in Adolescent Girls
||Polycystic Ovary Syndrome - Obesity - Hyperandrogenism
Women with Polycystic ovary syndrome (PCOS) can have unwanted facial or male-patterned body
hair, irregular menstrual periods, or no menstrual periods excess body weight, and
infertility. It also results in elevated androgen levels such as testosterone. In women
with PCOS, the majority of excess androgens are produced by the ovaries. However, it is
unknown whether the ovaries are fully active during early puberty. The purpose of this
study is to determine how the ovaries contribute to the production of male hormones in the
body during different stages of puberty, so that it can be better understood why some
females have excess androgens.
- 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
- 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
- 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.
Christine Burt Solorzano, MD
University of Virginia Center for Research in Reproduction
Michelle Y. Abshire, PhD
Christine Burt Solorzano, MD
||Charlottesville, Virginia 22908
Michelle Y Abshire, PhD
Site Status: Recruiting
||April 23, 2014
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