Clinical trial: The Effects of Natesto For Treatment Of Hypogonadism On Maintenance Of Spermatogensis. (NCT04717362)

Eligibility criteria:
Inclusion Criteria:

          -  1. Voluntarily sign and date the study consent form(s) which have been approved by an
             Institutional Review Board (IRB). Written consent must be obtained prior to the
             initiation of any study procedures.

             2. Male between 18 and 64 years of age, inclusive, with documented onset of
             testosterone induced hypogonadism with impaired semen parameters who are attempting to
             achieve a successful pregnancy.

             3. Documented diagnosis of primary hypogonadism (congenital or acquired) or
             hypogonadotropic hypogonadism (congenital or acquired).

             4. Serum total testosterone < 350 ng/dL based on 2 consecutive blood samples obtained
             1-4 weeks apart between 6 and 10 AM following an appropriate washout of current
             androgen replacement therapy; with clinical symptoms of hypogonadism such as
             diminished energy and sexual function; and/or a decreased sperm count (<20 million
             sperm/mL semen).

             5. Discontinued current testosterone replacement treatment and completed a washout of
             4 weeks following androgen treatment (excluding Testopel TM). Washout must be
             completed prior to collection of baseline serum testosterone samples to determine
             study eligibility.

             6. Judged to be in good general health as determined by the principal investigator
             based upon the results of a medical history, physical examination, vital signs, and
             laboratory profile.

        Exclusion Criteria:

          -  1. History of significant sensitivity or allergy to androgens, castor oil or product
             excipients.

             2. Clinically significant findings in the pre-study examinations including abnormal
             breast examination requiring follow-up.

             3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS
             score > 19 points.

             4. Body mass index (BMI) ≥ 35 kg/m2.

             5. History of vasectomy.

             6. Clinically significant abnormal laboratory value, in the opinion of the
             investigator, in serum chemistry, hematology, or urinalysis including but not limited
             to:

               1. Baseline hemoglobin > 16 g/dL

               2. Hematocrit < 35% or > 50%

               3. PSA > 4 ng/mL and age >40

                  7. History of seizures or convulsions, including febrile, alcohol or drug
                  withdrawal seizures.

                  8. History of any clinically significant illness, infection, or surgical
                  procedure within 4 weeks prior to study drug administration.

                  9. History of stroke or myocardial infarction within the past 5 years.

                  10. History of, or current or suspected, prostate or breast cancer.

                  11. History of diagnosed, severe, untreated, obstructive sleep apnea.

                  12. History of abuse of alcohol or any drug substance in the opinion of the
                  investigator within the previous 2 years.

                  13. History of nasal disorders such as nasal polyps; nasal septal perforation;
                  nasal surgery; nasal trauma resulting in nasal fracture within the previous 6
                  months or nasal fracture that caused a deviated anterior nasal septum; sinus
                  surgery or sinus disease

                  14. Donation or loss of 550 mL or more blood volume (including plasmapheresis) or
                  receipt of a transfusion of any blood product within 12 weeks prior to the start
                  of treatment.

                  15. Inadequate venous access for collection of serial blood samples required for
                  pharmacokinetic profiles.

                  16. Receipt of any investigational product within 4 weeks or within 5 half-lives
                  prior to the start of treatment.

                  17. Inability to understand and provide written informed consent for the study.

                  18. Considered by the investigator or the sponsor-designated physician, for any
                  reason, that the subject is an unsuitable candidate to receive Natesto.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years

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? Contradiction