Clinical Research Directory

Inclusion/exclusion criteria: * Age 18 years and older, * Confirmed diagnosis of HH with * Low testosterone or estradiol, * Low or low-normal gonadotropin levels, * Thyroid stimulating hormone (TSH) and prolactin within the reference range, * Absence of abnormal pituitary or hypothalamic findings on Magnetic resonance imaging (MRI), * All other medical conditions stable and well controlled, * No prescription medications known to affect reproductive endocrine function for at least 2 months or for 5 half-lives of the drug (whichever is shorter) except for medications used to treat the subject's reproductive condition, * No history of a medication reaction requiring emergency medical care, * No illicit drug use, * No excessive alcohol consumption (\<10 drinks/week), * Normal blood pressure (BP), (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg), * White blood cell, platelet counts, and TSH between 90% of the lower limit and 110% of the upper limit of the reference range, * Prolactin below 110% of the upper limit of the reference range, * Hemoglobin * Women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women, * Men: on adequate testosterone replacement therapy: normal male reference range, * Blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT) not elevated, * For women, * Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration), * Not breastfeeding and not pregnant.