Eligibility Details:
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.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
