Clinical trial: Exercise and Testosterone Therapy in Elderly Men With Physical Frailty (NCT00345969)

Eligibility criteria:
Inclusion Criteria:

          -  Male, age 65 years and older

          -  Total serum testosterone level < 350 ng/dl

          -  Total Modified Physical Performance Test Score <28

        Exclusion Criteria:

          -  Inability to walk 50 feet independently

          -  Current use of estrogen, progestin, or androgen containing compound

          -  Diagnosis of dementia of severity sufficient to interfere with informed consent or
             compliance with the protocol, or a score of 11 or greater on the Short Blessed Test of
             Orientation, Memory and Concentration

          -  Visual or hearing impairments that interfere with following directions

          -  Cardiopulmonary disease (recent MI, unstable angina or CHF, etc.), neuromuscular
             impairments, or unstable medical condition that would contraindicate progressive
             resistance exercise training

          -  History of prostate cancer or hormone dependent neoplasia

          -  PSA level > 4 ng/ml

          -  Serum liver transaminase levels of greater than 2 standard deviations above normal

          -  Use of drugs for osteoporosis for less than 1 year

          -  Current participation in a vigorous exercise or weight-training program more than once
             per week

          -  History of sleep apnea requiring use of CPAP

          -  Uncontrolled thyroid disease

          -  Diagnosis of cancer within the past 5 years other than superficial skin cancer
             (squamous or basal cell)

          -  hematocrit > 50%

          -  AUA symptom score > 16.

          -  History of alcohol or substance abuse

          -  Presence of severe facial acne

          -  Active symptoms of depression with GDS score > 5 and symptoms severe enough to cause
             >5% weight loss in previous 3 months or interfere with research assessments
Male
No healthy subjects accepted to join the trial.
Subject must be at least 65 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? 0