Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

This is an interventional other trial for Hypogonadotropic Hypogonadism Read More

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.