Clinical trial: Administration of Kisspeptin to Subjects With Reproductive Disorders (NCT00914823)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? Entailment