Clinical trial: Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement (NCT00752869)

Eligibility criteria:
Inclusion Criteria:

          1. Subjects currently on stable testosterone replacement therapy for 3 months' duration
             using either the approved transdermal products Androgel® or Testim®, or injections of
             testosterone enanthate or cypionate with a morning serum testosterone concentration
             within the normal range (300 - 1000 ng/dl). These will dispensed either by
             prescription or for injections by the PI or co-PI in the office.

          2. Total Serum PSA >1.5 - 10 ng/mL

               -  If the total serum PSA is >4ng/mL, the investigator, or a qualified urologist,
                  will perform a 12-core prostate biopsy prior to entry unless such a biopsy has
                  already been performed within the past 6 months.

               -  If the PSA rises above 4 during any time of the study, the patient will be
                  referred to urology for biopsy.

               -  Patients with any suspicious rise in PSA of >1.0 ng/ml/yr will have a repeat PSA
                  performed within one month of the original value. If the rise in PSA remains >1.0
                  ng/ml/yr, the patient will undergo a prostate biopsy.

               -  b. If the individual has had a negative biopsy more than 6 months previously,
                  with documentation of stable PSA since that time, ie, no sustained increase
                  >1.0ng/ml.

          3. Subject is able to read and comprehend the informed consent document.

          4. If the subject is on current replacement therapy for hypopituitarism or other multiple
             endocrine abnormalities, the subject must be on stable doses of thyroid hormone and/or
             adrenal replacement hormones for at least 14 days prior to enrollment.

        Exclusion Criteria:

          1. Use of medications including those interactive with dutasteride from prior studies

          2. Hematocrit greater than 51%

          3. Prostate cancer in men found to have a prostate nodule on initial exam and subsequent
             positive biopsy

          4. No prostate surgery within 2 months of entry

          5. No prior use of finasteride, dutasteride within 6 months prior

          6. A history of hepatic impairment or abnormal liver function tests (defined as ALT, AST,
             alkaline phosphatase or bilirubin >1.5 times the upper limit of normal) with the
             exception that bilirubin elevations up to 2.0 times the upper limit of normal in the
             presence of normal liver enzymes will be permitted in patients with documented
             Gilbert's Disease. Subjects with Gilbert's disease not to be excluded.

          7. No serum creatinine greater than 2.0 times upper limit of normal

          8. No history of alcohol abuse with last 12 months

          9. Has received any medication in a clinical trial within 2 months of enrollment

         10. Use of anti-androgens, estrogens or coumadin

         11. A history or evidence of newly discovered prostate cancer (e.g. positive biopsy or
             ultrasound, suspicious DRE). In patients with suspicious ultrasound or DRE, including
             patients with a focal nodule, biopsy shall be performed by a qualified urologist upon
             study entry unless one was performed and found to be negative within the preceding 6
             months.

         12. History of or current prostate or breast cancer

         13. Baseline EKG with clinically significant abnormal rhythm or abnormal QT interval

         14. Systolic blood pressure above 170mmHg or diastolic blood pressure above 90 mm Hg on
             baseline physical exam

         15. Clinically significant peripheral edema on baseline physical exam

         16. History of sleep apnea

         17. History of psychiatric disorders or major depression

         18. Consumption of grapefruit juice within 7 days of enrollment or is unwilling to
             eliminate use of grapefruit juice during the study period

         19. History of allergy to study medication

         20. Hemoglobin A1c > 9% in a non-insulin dependent diabetic

         21. Subjects with abnormal thyroid function

         22. Subjects with significantly elevated triglycerides
Male
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 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