Administration of Kisspeptin to Subjects With Reproductive Disorders
The goal of this study is to learn about the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that causes the release of other hormones, including gonadotropin-releasing hormone (GnRH) in the body.
• 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:
⁃ 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, 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.
⁃ 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:
⁃ 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.
⁃ Women with Polycystic Ovarian Syndrome (PCOS)
∙ Confirmed diagnosis of PCOS,
‣ If needed, additional labs and imaging tests may be performed.
⁃ 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.