Clinical trial: Vogelxo(R) ABPM Study in Hypogandal Men (NCT04558567)

Eligibility criteria:
Inclusion Criteria:

          1. Adult male whose age is between 18 and 80 years, inclusive, at the time of screening.

          2. Considered by the investigator to be in good general health as determined by medical
             history, clinical laboratory test results, vital sign measurements, 12-lead
             electrocardiogram (ECG) results, and physical examination findings at screening.

          3. Meets the study definition of clinical hypogonadism, as evidenced by serum
             testosterone concentrations:

               1. Two serum testosterone concentrations < 300 ng/dL collected in the morning
                  (between 0630 hours and 1000 hours local time) on at least 2 days separated by a
                  minimum of 48 hours.

               2. Presence of at least 1 sign or symptom that may be related to low testosterone
                  values and is/are consistent with hypogonadism

          4. Naïve to testosterone replacement, clomiphene, compounded or over-the-counter
             androgenic steroid derivatives and dehydroepiandrosterone, including investigational
             products that may affect the reproductive hormonal system within the past 2 months.

          5. Willingness and the ability to apply topical testosterone gel as instructed by the
             study staff and comply with the requirements of this study protocol.

          6. Intact skin surfaces on the upper arms and shoulders where the topical testosterone
             will be applied.

        Exclusion Criteria:

          1. Two testosterone concentrations < 100 ng/dL during screening.

          2. Prolactin concentration > 1 x upper limit of normal (ULN).

          3. Current or recurrent ulcer, erosion, lichenification, inflammation psoriasis, eczema
             or use of topical corticosteroids on the upper arms and shoulders. Tattoo application
             or removal in the region of study drug application.

          4. Known skin intolerance to alcohol or allergy to any of the ingredients of the study
             drug.

          5. History of treatment with growth hormone, anti-estrogen or estrogen treatment within
             90 days prior to screening.

          6. Currently taking glucocorticoids > 7.5 mg prednisone equivalent per day (eg,
             hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg) for 1 week
             before SV1 and through Day 1, and any use of opioids within 5 half-lives prior to Day
             1.

          7. Currently taking, unstable doses within 14 days prior to first administration of study
             drug or anticipated to receive any antihypertensive medications, over-the-counter
             medications, supplements or herbal medicines known to affect blood pressure during
             study participation. These medications or supplements include diet pills (eg,
             phenylpropanolamine, sibutramine), nasal decongestants (eg, phenylephrine
             hydrochloride, pseudoephedrine, naphazoline hydrochloride), certain stimulants (eg,
             amphetamine, methylphenidate dexmethylphenidate, dextroamphetamine), monoamine oxidase
             inhibitors (MAO), atypical antipsychotics (eg, clozapine, olanzapine).

          8. History of prostate (current or in the past) or breast cancer.

          9. Severe lower urinary tract symptoms as indicated by an International Prostate Symptom
             Score (I-PSS) > 19.

         10. Prostate-specific antigen (PSA) > 3.0 ng/mL; men treated with 5-alpha reductase
             inhibitors (eg, dutasteride, finasteride) are eligible for participation as long as
             PSA levels are not > 1.5 ng/mL.

         11. Body mass index > 50 kg/m2.

         12. Sitting SBP < 80 mm Hg and > 150 mm Hg or sitting DBP < 50 mm Hg and > 100 mm Hg at
             any point during screening.

         13. HbA1c > 11% at screening.

         14. A current condition, therapy, laboratory abnormality, history of clinically
             significant medical or psychiatric conditions or other circumstance or reasons which,
             in the opinion of the investigator or the study staff, might pose a risk to the
             subject, make participation not in the subject's best interest, confound the results
             of the study (eg, if subject cannot comply with requirements of the study), make the
             subject an unsuitable candidate to receive study drug, or interfere with the subject's
             participation for the full duration of the study.

         15. History, suspicion, or evidence of significant drug or alcohol abuse or illicit
             steroid use within the previous 12 months prior to screening, as determined by the
             investigator.

         16. The subject is a smoker or has used nicotine or nicotine-containing products (eg,
             snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6
             months before the first dose of study drug.

         17. Clinical laboratory analysis shows any of the following abnormal results:

               -  Hematocrit > 50%

               -  Alanine aminotransferase or aspartate aminotransferase > 3 × ULN

         18. Severe or end-stage chronic kidney disease documented by eGFR < 30 mL/min.

         19. Subject works night shifts.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 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