Clinical trial: H-36731: Finasteride in Management of Elevated Red Blood Cells (NCT02548117)

Eligibility criteria:
Inclusion Criteria:

          -  Adult males 18 years of age or older

          -  Currently is being treated for hypogonadism with testosterone therapy using injectable
             testosterone.

          -  Must not have erythrocytosis (defined as a hematocrit of 52% or higher) attributable
             to other medication or medical condition

          -  Agree not to initiate any other treatment for erectile dysfunction (ED), including
             herbal and over- the-counter (OTC) medications, for the duration of the study.

          -  Must not already be taking finasteride or other 5-alpha reductase inhibitor

        Exclusion Criteria:

          -  Men not currently using testosterone supplementation therapy or men on non-injectable
             testosterone therapy

          -  Prior history of anabolic steroid use, but have not used for at least 6 months

          -  Prior history of testosterone use, but have not used for at least 6 months

          -  Men who are already taking finasteride

          -  Untreated or inadequately treated hypothyroidism

          -  Significant history of allergy and/or sensitivity to the drug products or excipients,
             including sensitivity to testosterone and/or finasteride

          -  Current use of any medications, herbal, and/or nutritional supplements that can
             interfere with testosterone level

          -  Currently receiving treatment with cancer chemotherapy or anti-androgens

          -  Any contraindication to testosterone therapy or finasteride

          -  History of luteinizing hormone-releasing hormone antagonist or agonist treatment

          -  History of clomiphene treatment in 6 months prior to Visit 1
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 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