Assessment of the Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Normal and Hyperandrogenemic Adolescent Girls (JCM010)
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)