Clinical Trial Details
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NCT00914823 : Administration of Kisspeptin to Subjects With Reproductive Disorders
PhasePhase 2
AgesMin: 18 Years Max: N/A
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 or for 5 half-lives of the drug (whichever is shorter) 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,

- no excessive alcohol consumption (<10 drinks/week),

- not currently seeking fertility,

- for women, not breastfeeding and not pregnant,

- if applicable, able to undergo appropriate washout from hormone therapy.

Physical Examination:

- normal blood pressure, (systolic BP < 140 mm Hg, diastolic < 90 mm Hg).

Laboratory Studies:

- white blood cell, platelet counts, and TSH between 90% of the lower limit and 110% of
the upper limit of the reference range,

- prolactin below 110% of the upper limit of the reference range with the exception of
participants with hyperprolactinemia who by definition will have elevated levels of

- hemoglobin

1. women: no less than 0.5 gm/dL below the lower limit of the reference range for
normal women,

2. men:

i. on adequate testosterone replacement therapy: normal male reference range,
testosterone replacement therapy: no lower than 0.5 gm/dL below the lower limit of
the reference range for normal women (> 11.5 gm/dL in our laboratory), as men with
hypogonadism off treatment have low serum testosterone levels which causes hemoglobin
concentrations to fall to the female range,

- BUN, creatinine, AST, ALT not elevated,

- for women, negative serum hCG pregnancy test at the time of screening (additional
urine pregnancy test will be conducted prior to drug administration).

Additional criteria based on subject population:

1. Men and women with hypogonadotropic hypogonadism: All subjects will have confirmed
diagnosis by low sex steroids in the setting of low or inappropriately normal
gonadotropins. If needed to verify clinical criteria, additional diagnostic labs and
imaging tests may be performed including but not limited to ferritin, prolactin, sex
steroids, FSH, LH and brain MRI.

2. Women with Polycystic Ovarian Syndrome (PCOS): All subjects will have a confirmed
diagnosis of PCOS as evidenced by 2 or more of the following: oligoamenorrhea,
clinical or biochemical hyperandrogenism, and polycystic ovarian morphology, and
exclusion of identifiable conditions that would result in this pattern. If needed to
verify clinical criteria, additional diagnostic labs may be drawn including but not
limited to 17-OHP, sex steroids, FSH, LH.

3. Men and women with hyperprolactinemia: All subjects will have confirmed diagnosis by
elevated levels of prolactin measured via blood test and MRI imaging confirming no
pituitary abnormality or a microprolactinoma (<10 mm). Patients with a
macroprolactinoma will be excluded. We will enroll subjects when they first present
with hyperprolactinemia prior to receiving medication or subjects being treated with
the dopamine agonist bromocriptine only. We will ask subjects being treated with
bromocriptine to complete a washout period prior to the kisspeptin administration
visit(s). The washout period will last at least 2 weeks. We will perform a blood test
prior to the kisspeptin administration visit(s) to confirm elevated levels of
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