Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

Inclusion Criteria

• •A. Healthy Subjects
• •All healthy subjects will meet the following criteria:
• •normal puberty with respect to onset and pace,
• •no difficulty with blood draws,
• •no prescription medications for at least 2 months with the exception of asthma medication (albuterol only), hypercholesterolemia medication and psychiatric medication,
• •no illicit drug use or excessive alcohol consumption (\>10 drinks/week),
• •no history of a medication reaction requiring emergency medical care,
• •normal physical exam and laboratory studies within protocol reference ranges.
• •Additional criteria based on subject population:
• •1. Healthy Men:
• •* between 21 and 40 years old,
• •* normal erectile and ejaculatory function, no history of reproductive disorders,
• •* testicular volume \>15 ml.
• •2. Healthy women:
• •* between 21 and 40 years old,
• •* not breastfeeding or pregnant,
• •* menstrual cycles between 25 and 35 days in duration with no more than 5 days variability in cycle duration,
• •* no evidence for androgen excess (hirsutism or acne),
• •3. Healthy postmenopausal women:
• •* between 48 and 60 years old,
• •* no menstrual periods within the last year,
• •* previous history of menstrual cycles between 25 and 35 days in duration, with no more than 5 days variability in cycle duration,
• •* if applicable, able to undergo washout from hormone therapy,
• •* no evidence for androgen excess (hirsutism or acne),
• •* negative screening for Factor V Leiden for those who might receive estradiol treatment as a part of this study.
• •B. Subjects with Reproductive Disorders
• •All subjects with reproductive disorders will meet the following criteria:
• •all medical conditions stable and well controlled, medications allowed include asthma medication (albuterol only), hypercholesterolemia medication and psychiatric medication,
• •no medications known to affect reproductive endocrine function for at least 2 months 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 or excessive alcohol consumption (\>10 drinks/week),
• •for women, not breastfeeding or pregnant,
• •if applicable, able to undergo appropriate washout from hormone therapy,
• •normal physical exam and laboratory studies within protocol reference ranges,
• •Additional criteria based on subject population:
• •1. Men and women with hypogonadotropic hypogonadism,
• •* 18 years or older,
• •* Confirmed diagnosis by low sex steroids in the setting of low or inappropriately normal gonadotropins,
• •* If needed, additional labs and imaging tests may be performed.
• •2. Agonadal men,
• •* Between 18 and 60 years old.