Clinical trial: A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism (NCT04274894)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of hypogonadism with the presence of at least one of the following symptoms
             that may be related to low testosterone values and is/are consistent with
             hypogonadism:

               -  Decreased sexual desire or libido

               -  Decreased spontaneous erections (e.g. morning erections)

               -  Decreased energy or fatigue/feeling tired

               -  Low mood or depressed mood

               -  Loss of body (axillary and pubic) hair or reduced shaving

               -  Hot flashes AND

          -  Confirmed by 2 serum testosterone levels < 300 ng/dL by blood samples drawn at least
             48 hours apart. These samples should be obtained between 5 am and 11 am local time.

          -  Blood pressure >100/60 mmHg and <140/90 mmHg.

        Exclusion Criteria:

          -  Unprovoked deep vein thrombosis (DVT), unprovoked pulmonary embolism (PE), or known
             thrombophilia.

          -  Polycythemia vera or secondary polycythemia, such as polycythemia due to untreated
             sleep apnea or severe chronic obstructive pulmonary disease

          -  Prostate or breast cancer

          -  Any active malignancy.

          -  Clinically significant medical conditions or any other reason that the investigator
             determines would interfere with participation in this study or would make the
             participant an unsuitable candidate to receive study drug.

          -  Work night shifts or is otherwise required to perform strenuous manual labor while
             wearing the Ambulatory Blood Pressure Monitor (ABPM).
Male
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? 1