›Inclusion and exclusion criteria, as posted
A. Healthy Subjects
All healthy subjects will meet the following criteria:
* normal puberty with respect to onset and pace,
* no chronic diseases,
* no difficulty with blood draws,
* no prescription medications for at least 2 months with the exception of seasonal allergy medications and hormone replacement therapy,
* 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, at least 11 periods/year, with no more than 5 days variability in cycle duration,
* no evidence for androgen excess (hirsutism or acne),
* at screening, negative hCG pregnancy test,
* negative screening for Factor V Leiden for those who might receive estradiol treatment as a part of this study.
3. Healthy postmenopausal women:
* between 50 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:
* 18 years or older,
* all medical conditions stable and well controlled,
* no prescription 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,
* for women, at time of screening negative hCG pregnancy test.
Additional criteria based on subject population:
1. Men and women with hypogonadotropic hypogonadism,
* 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. Women with Polycystic Ovarian Syndrome (PCOS)
* Confirmed diagnosis of PCOS,
* If needed, additional labs and imaging tests may be performed.
3. Men and women with hyperprolactinemia
* confirmed diagnosis of elevated levels of prolactin measured via blood test,
* no pituitary adenoma OR a microprolactinoma (\<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded,
* willing to complete a dopamine agonist washout.