Clinical trial: TRADE-Testosterone Replacement and Dutasteride Effectiveness (NCT00194675)

Eligibility criteria:
Inclusion Criteria:

          -  Generally healthy older men 50 years old or older

          -  Hypogonadism; low testosterone (total T less than 280 ng/dL on one occasion or an
             average of equal to or less than 300 ng/dl on two occasions)

          -  Prostate volume equal to or more than 30 cc by prostate MRI

          -  Prostate Specific Antigen (PSA) equal to or more than 1.5 ng/mL and equal to or less
             than 10 ng/mL

          -  Subjects with a PSA greater than 4.0 ng/ml must have a negative prostate biopsy

          -  International Prostate Symptom Score (IPSS) greater than or equal to 8 and less than
             or equal to 20 at screening

          -  Comply with study procedures for the full 10 months

          -  No contraindications to MRI

        Subjects with symptomatic Benign Prostatic Hyperplasia (BPH) will be recruited from the
        Urology and General Internal Medicine Clinics at the VA Puget Sound Health Care System and
        University of Washington Medical Center in Seattle.

        Exclusion Criteria:

          -  A history of prostate or breast cancer

          -  Invasive therapy for BPH in the past

          -  History of acute urinary retention in the 3 months prior to screening

          -  Previous treatment with a 5 alpha-reductase inhibitor (finasteride or dutasteride)

          -  Medical therapy for BPH within the past month (alpha-blocker, phytotherapy)

          -  Use of androgenic or antiandrogenic drugs in the past year

          -  History or evidence of prostate cancer including suspicious DRE or history of
             high-grade PIN on prostate biopsy.

          -  Severe systemic illness (renal, liver, cardiac, lung disease, cancer, diabetes)

          -  Known untreated obstructive sleep apnea

          -  Hematocrit greater than 52

          -  Severe skin disease which may interfere with testosterone gel absorption

          -  Hypersensitivity to any of the drugs used in the study

          -  History of a bleeding disorder or need for chronic anticoagulation

          -  Participation in a drug study concurrently or in the last 90 days

          -  History or current evidence of drug or alcohol abuse within 12 mo.

          -  Weight more than 300 lbs.
Male
Accepts Healthy Volunteers
Subject must be at least 50 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