Clinical trial: A Dose Ranging Study to Examine Testagen® TDS-Testosterone 5% (NCT01894308)

Eligibility criteria:
Inclusion Criteria:

          1. Hypogonadal Male subjects - morning testosterone level ≤300 ng/dL (10.4 ng/L).

          2. 18 and 75 years of age, inclusive.

          3. The subject is willing and able to read, understand the Subject Information Sheet and
             provide written informed consent.

          4. The subject has a body mass index (BMI) within 18-30 kg/m2.

          5. The subject is in otherwise good health as determined by medical history and physical
             examination.

          6. The subject is a non-smoker.

          7. The subject must agree to comply with the placement of an indwelling catheter on two
             separate occasions and the drawing of blood samples for the pharmacokinetic
             assessments.

          8. The subject is willing and able to comply with all testing and requirements defined in
             the protocol.

          9. The subject is willing and able to return to the study site for all visits.

        Exclusion Criteria:

          1. The subject has any relevant deviations from normal in physical examination,
             electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the
             investigator, particularly an elevated PSA reading >4.0 ng/ml or ALT and AST greater
             than 2 times the upper limit of normal, clinically significant anemia (hematocrit
             <35%) or renal dysfunction (creatinine >2mg/dL), active deep vein thrombosis,
             thromboembolic disorders or history of these conditions.

          2. The subject has had a clinically significant illness within 30 days preceding entry
             into this study.

          3. The subject has a history of significant neurological, hepatic, renal, endocrine,
             cardiovascular, gastrointestinal, pulmonary, or metabolic disease.

          4. The subject has a known allergy or history of hypersensitivity to Testosterone or
             similar compounds.

          5. The subject has used any prescription medication within 14 days or over-the-counter
             (OTC) medication or alcohol within 48 hours of dosing or intends to use any
             prescription or OTC medication during the study that may interfere with the evaluation
             of study medication.

          6. The subject has donated or lost a significant volume of blood (>450 mL) within four
             (4) weeks of the study, and their haemoglobin concentration and haematocrit have not
             returned to within 5% of normal.

          7. The subject has a Hematocrit level > 51%

          8. The subject has a history of substance abuse or a current positive urine drug screen
             or urine alcohol test.

          9. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks
             per week for males).

         10. Subjects who have received an investigational drug or have used an investigational
             device in the 30 days prior to study entry.

         11. Subjects with an American Urological Association System Index for Prostatism score
             greater than 7

         12. Subjects with a history of prostate or breast carcinoma.

         13. Subjects with prostatic mass on screening physical examination.

         14. Subjects with a history of significant skin disease.

         15. Subjects with a history of sleep apnea.

         16. Subject with a partner with a history of breast cancer.

         17. Subject with a partner of child bearing potential who is not willing to use adequate
             contraception for the duration of the trial.

         18. Subject whose partner is pregnant.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 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? 1