Clinical trial: Cardiovascular Outcomes of Low Testosterone (NCT02758431)

Eligibility criteria:
Inclusion Criteria:

          1. Men aged 18-40 years and 50-75 years

          2. Chronically low testosterone group will have testosterone concentrations <300 ng/dl,
             and young and older normal testosterone groups will have testosterone levels 400-1000
             ng/dl

          3. No use of sex hormones for at least 1 year

          4. Body mass index <40 kg/m2

          5. Nonsmokers

          6. Resting blood pressure <160/90 mmHg

          7. Fasting plasma glucose <126 mg/dL

          8. Healthy, as determined by medical history, physical examination, standard blood
             chemistries (chemistry panel, complete blood clot and circulating thyroid levels) and
             a graded exercise stress test with monitoring of blood pressure and electrocardiogram
             (ECG)

          9. Sedentary or recreationally active (< 3 days/wk of vigorous aerobic exercise)

         10. No use of medications that might influence cardiovascular function including
             anti-hypertensive, lipid lowering medications, and corticosteroids

         11. No use of vitamin supplements or anti-inflammatory medications, or willing to stop 1
             month prior and throughout the study.

        Exclusion Criteria:

          1. Contraindications to:

               1. Gonadotropin releasing hormone (GnRH) antagonist

               2. Testosterone gel and aromatase inhibitor including hypersensitivity to Acyline,
                  Androgel®, Arimidex®

               3. Extrinsic peptide hormones, mannitol, GnRH or any other GnRH analogs

          2. History of or active prostate or breast cancer or other sex hormone-dependent
             neoplasms

          3. Pre-existing or active cardiac, renal or hepatic disease

          4. History of stomach ulcer or bleeding

          5. History of epilepsy or other seizure disorder

          6. Diabetes

          7. Active infection

          8. Disease that affects the nervous system

          9. Abnormal resting ECG

        Additionally, men participating in the gonadal suppression intervention study will do so
        with the understanding that they will be randomly assigned to study groups that involve
        either GnRH antagonist plus testosterone gel plus placebo tablet (33% chance), GnRH
        antagonist plus testosterone gel plus aromatase inhibitor tablet (33% chance) or GnRH
        antagonist plus placebo gel plus placebo tablet (33% chance).
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 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? Contradiction