Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

Please contact study staff for a detailed description.

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:

• Healthy Men:

• between 21 and 40 years old,
• normal erectile and ejaculatory function, no history of reproductive disorders,
• testicular volume >15 ml.
• 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),
• 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:

• 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.
• Agonadal men,

• Between 18 and 60 years old.