Clinical trial: Comparison of Sleep-wake LH Frequency in Peripubertal Girls With and Without Hyperandrogenemia (NCT00930007)

Eligibility criteria:
Inclusion Criteria:

          -  Early to midpubertal girls (late Tanner 1 [i.e., estradiol > 20 pg/ml] to Tanner 3)

          -  Premenarcheal

          -  Approximate ages, 8-15 years

        Exclusion Criteria:

          -  BMI-for-age < 5th percentile

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

          -  Being a study of GnRH pulse regulation in adolescent girls with and without HA, boys
             are excluded

          -  Obesity associated with a diagnosed (genetic) syndrome (e.g., Prader-Willi syndrome,
             leptin deficiency), obesity related to medications (e.g., glucocorticoids), etc.

          -  Pregnancy or lactation

          -  Virilization

          -  Total testosterone > 150 ng/dl (confirmed on repeat)

          -  DHEAS > upper limit of age-appropriate normal range (confirmed on repeat) (mild
             elevations may be seen in adolescent HA, and elevations < 1.5 times the
             age-appropriate upper limit of normal will be accepted in such girls)

          -  Follicular phase 17-hydroxyprogesterone > 250 ng/dl (for girls < 12 years old) or >
             300 ng/dl (for girls 12 and older) (confirmed on repeat), which suggests the
             possibility of congenital adrenal hyperplasia. NOTE: If an elevated follicular
             17-hydroxyprogesterone is confirmed on repeat testing, an ACTH stimulated
             17-hydroxyprogesterone < 1000 ng/dl will be required for study participation

          -  History of premature adrenarche (i.e., appearance of pubic and/or axillary hair before
             age 8)

          -  A previous diagnosis of diabetes

          -  Fasting glucose ≥ 126 mg/dl, or a hemoglobin A1c > 6.5% (confirmed on repeat)

          -  Abnormal TSH (confirmed on repeat) (subjects with adequately treated hypothyroidism,
             reflected by normal TSH values, will not be excluded)

          -  Abnormal prolactin (confirmed on repeat) (mild elevations may be seen in HA girls, and
             elevations < 1.5 times the upper limit of normal will be accepted in this group)

          -  Evidence of Cushing's syndrome by history or physical exam (e.g., history of impaired
             growth in children, striae)

          -  Hematocrit < 36% and hemoglobin < 12 g/dl (confirmed on repeat)

          -  Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected
             congestive heart failure; asthma requiring intermittent systemic corticosteroids;
             etc.)

          -  Persistent liver test abnormalities (confirmed on repeat), with the exception that
             mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome

          -  Persistently abnormal sodium, potassium, or elevated creatinine concentration
             (confirmed on repeat)

          -  Bicarbonate concentrations < 20 or > 30 (confirmed on repeat)

          -  No medications known to affect the reproductive system, glucose metabolism, lipid
             metabolism, or blood pressure can be taken in the 3 months prior to the first
             inpatient GCRC study (or in the 2 months prior to screening)

               -  Such medications include oral contraceptive pills, progestins, metformin,
                  glucocorticoids, psychotropics, and sympathomimetics/stimulants (e.g.,
                  methylphenidate)

               -  Patients taking restricted medications will be excluded unless written permission
                  (for the subjects to discontinue the medication) is received from the subject's
                  physician

          -  Weight < 22 kg is an absolute exclusion criterion (to ensure safe blood withdrawal)
Female
Accepts Healthy Volunteers
Subject must be at least 8 Years old.
Subject must be at most 15 Years

Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? Contradiction