Eligibility Details:
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.