Clinical trial: Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial. (NCT00104572)

Eligibility criteria:
-  INCLUSION CRITERIA:

               1. Men age 65 years or older

               2. Serum testosterone level less than or equal to 350 ng/dl

               3. Subject is able to complete an informed consent

        EXCLUSION CRITERIA:

          1. History of Stroke

          2. History of Dementia

          3. History of Diabetes

          4. Blood pressure at rest of > 155/90 mmHg. Elevated systolic or diastolic reading
             renders subject ineligible

          5. Chronic medical condition, i.e. congestive heart failure

          6. Arthritis, severe enough to prevent completion of the strength testing, history of
             joint replacement of knees or hip.

          7. Inability to walk 50 meters

          8. Known disease of the bone and/or taking medications to treat osteoporosis, i.e.

             Fosamax, Evista, Miacalcin

          9. History of Gastric surgery

         10. History of prostate cancer or any other cancers, including blood dyscrasias

         11. History of severe benign prostatic hyperplasia (causing urinary problems)

         12. History of heart attack or open-heart surgery within the past 6 months

         13. Use of steroids within the past 3 months, including prednisone and/or cortisone
             injections, and inhaled steroids. Topical steroid cream is acceptable.

         14. If you do not agree to refrain from taking the drugs Viagra, Cialis or Levitra for the
             duration of the study

         15. Use of anabolic steroids, i.e. testosterone, (or any analog of testosterone)
             Dehydroepiandrosterone or any growth promoters i.e. growth hormone itself or analogs
             of growth hormone

         16. Use of anti-androgen medications, i.e. Aldactone, Tagamet, Proscar, estrogens

         17. Use of Dilantin or Phenobarbital

         18. Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of
             wine or cocktail daily)

         19. Currently smokes any tobacco product

         20. Having started a new medication during the past three months which may interfere with
             the outcome measures of the study

         21. Polycythemia

         22. Prostate specific antigen > 4.0 ng/dl

         23. Hematocrit < 36

         24. Liver function tests greater than 2 times upper normal limits or abnormal
             electrolytes, calcium or Parathyroid hormone , at the discretion of the investigator

         25. Mini Mental Status Exam score less than or equal to 24
Male
Accepts Healthy Volunteers
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? Contradiction