Clinical trial: Assessment of the Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition (NCT01425541)

Eligibility criteria:
Inclusion Criteria:

          -  Girls ages 8 to 18

          -  Hyperandrogenemic (testosterone level > 0.4 ng/mL and/or hirsutism)

          -  Normal screening labs (with exception of the expected hormonal abnormalities inherent
             in hyperandrogenemia)

        Exclusion Criteria:

          -  Abnormal screening labs (with exception of the expected hormonal abnormalities
             inherent in hyperandrogenemia)

          -  Congenital adrenal hyperplasia.

          -  Hemoglobin <12 mg/dL or 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.)

          -  Weight < 31 kg

          -  History of peanut allergy, deep venous thrombosis, breast cancer, endometrial cancer,
             or cervical cancer

          -  On hormonal medications (including oral contraceptive pills) or on medications known
             to affect the reproductive axis within 3 months of the study

          -  Pregnant or breastfeeding

          -  Participation in a research study within the past 30 days that involved taking a study
             drug.

          -  Participation in a research study that involved taking up to or greater than 473 ml's
             of blood within the past 60 days.

          -  Cigarette smoking

          -  History of surgery that required bedrest within the past 30 days

          -  Family history of hypercoagulability or unexplained thromboembolic disease (not in
             setting of bedrest, surgery, or malignancy)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 18 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? 0