Clinical trial: Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™ (NCT02937740)

Eligibility criteria:
Inclusion Criteria:

          -  Hypogonadal male between 18 and 65 years of age, inclusive;

          -  Able to understand and provide signed informed consent;

          -  Have documented total serum testosterone levels ≤300 ng/dL;

          -  Are currently being treated with any form of a topical testosterone replacement
             therapy for at least three months, or are treatment-naive.

        Exclusion Criteria:

          -  In the opinion of the Investigator, significant intercurrent disease of any type, in
             particular liver, kidney, heart disease, stroke, or psychiatric illness;

          -  History of pituitary or hypothalamic tumors or history of any malignancy (including
             breast and prostate cancers) excluding basal cell or squamous cell carcinoma of the
             skin curatively treated by surgery;

          -  Prostatomegaly or history of abnormal PSA levels (>10.0 ng/mL). If PSA is >10 ng/mL, a
             recent negative biopsy must be documented (within the last 12 months);

          -  History of nasal disorders, nasal or sinus surgery, nasal fracture within the previous
             6 months or nasal fracture that caused a deviated anterior nasal septum surgery,
             mucosal inflammatory disorders, specifically Sjogren's syndrome;

          -  Use of any form of intranasal medication delivery other than periodic short-term (less
             than 3 days) use of sympathomimetic decongestants;

          -  History of severe adverse drug reactions to testosterone therapies;

          -  History or current evidence of abuse of alcohol or any drug substance;

          -  Current treatment with other androgens (e.g., dehydroepiandrosterone [DHEA]), anabolic
             steroids, or other sex hormones;

          -  Treatment with estrogens, gonadotropin-releasing hormone (GnRH) agonists, or growth
             hormone within the previous 12 months;

          -  Treatment with drugs that interfere with the metabolism of testosterone, such as
             anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole,
             spironolactone, or testolactone;

          -  Poor compliance history;

          -  Participation in any other research study during the conduct of this study or 30 days
             prior to the initiation of this study.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 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? Entailment