Clinical trial: Effect of Testosterone Gel Replacement on Fat Mass in Males With Low Testosterone Levels and Diabetes (NCT00440440)

Eligibility criteria:
Inclusion Criteria:

          -  Males with age 35-75 years inclusive.

          -  Evidence of hypogonadism: Hypogonadism will be defined as low total testosterone (<300
             ng/dL) and low calculated free testosterone (below 6.5ng/dL; calculated using
             testosterone and SHBG). Testosterone levels will be measured between 8 and 10 am.
             Subjects who have normal total but low free testosterone levels (or vice versa) will
             be asked to come again after one week to have their testosterone levels re-measured.
             They will be included in the study in their free and total testosterone levels are low
             on re-measurement.

          -  Type 2 diabetes

          -  Hemoglobin A1c <8.0 %

          -  Subjects on medications for diabetes will be allowed as long as they are on stable
             doses of these compounds for at least 6 weeks. The dose of thiazolidinediones will
             have to be stable for 3 months prior to the study. The dosage of diabetic medications
             will not be changed during the study.

        Exclusion Criteria:

          -  Coronary event or procedure (myocardial infarction, unstable angina, coronary artery
             bypass, surgery or coronary angioplasty) in the previous four weeks

          -  Hepatic disease (transaminase > 3 times normal)

          -  Renal impairment (serum creatinine > 1.5)

          -  Chronic steroid therapy

          -  Use of testosterone or other androgens (such as DHEA) in the last 3 months

          -  Panhypopituitarism

          -  HIV or hepatitis C

          -  Subjects will be excluded from the study for history of prostate or breast cancer,
             gonadal endocrine disorders

          -  Current or recent history of major psychiatric illness, significant uncontrolled
             systemic illness

          -  Sleep apnea

          -  History of alcoholism or substance abuse within the past year

          -  History of taking other drugs that might interfere with the results of the study (ie,
             Lupron, finasteride, spironolactone, cimetidine, antiandrogens, estrogens, p450 enzyme
             inducers, barbiturates)

          -  Abnormal prostate evidenced by prostatic symptoms, prostatic masses or induration on
             rectal examination, elevated levels of prostate specific antigen (>4 ng/mL; subjects
             with PSA levels between 2.5-4 ng/mL will be permitted if prostate biopsy is negative)
             or positive biopsy, a urine flow rate of less than 12 mL/s, or an International
             Prostate Symptom Score greater than 19

          -  Hematocrit greater than 50%

          -  Body weight >300 lbs (this is the maximum weight that can be accommodated on DEXA or
             MRI machines.

          -  The subject has systolic blood pressure >170mmHg or diastolic blood pressure >100 mmHg
             while on or off anti-hypertensive treatment.

          -  Generalized skin disease that could affect the absorption of testosterone gel (ie,
             psoriasis);

          -  Morning prolactin level greater than 40 mg/mL

          -  Subjects with serum fasting triglyceride concentration > 500 mg/dL at screening or
             with history of hypertriglyceridemia-induced pancreatitis.

          -  Participation in any other concurrent clinical trial

          -  Any other life-threatening, non-cardiac disease

          -  Use of an investigational agent or therapeutic regimen within 30 days or 5 half-lives
             (which ever is longer) preceding the first dose of study medication.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 35 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? 0