Clinical trial: Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism (NCT04648969)

Eligibility criteria:
Inclusion/exclusion criteria:

          -  Age 18 years and older,

          -  Confirmed diagnosis of HH with

               -  Low testosterone or estradiol,

               -  Low or low-normal gonadotropin levels,

               -  Thyroid stimulating hormone (TSH) and prolactin within the reference range,

               -  Absence of abnormal pituitary or hypothalamic findings on Magnetic resonance
                  imaging (MRI),

          -  All other 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),

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

          -  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,

          -  Hemoglobin

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

               -  Men: on adequate testosterone replacement therapy: normal male reference range,

          -  Blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine
             transaminase (ALT) not elevated,

          -  For women,

               -  Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of
                  screening (additional urine pregnancy test will be conducted prior to drug
                  administration),

               -  Not breastfeeding and not pregnant.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
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