Clinical trial: A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels (NCT01419236)

Eligibility criteria:
Inclusion Criteria:

          -  Total testosterone level <10.4 nanomoles per liter (nmol/L) [300 nanograms per
             deciliter (ng/dL)] at screening

          -  Presents with 1 or more of the following symptom(s) of ejaculatory dysfunction:
             delayed ejaculation, anejaculation, decreased force of ejaculation, or decreased
             ejaculatory volume, as determined by investigator assessment

          -  Prostate-Specific Antigen (PSA) <4 nanograms per milliliter (ng/mL) at screening

        Exclusion Criteria:

          -  Sexual partner who is or becomes pregnant at any time during the study

          -  Premature ejaculation as determined by investigator assessment

          -  Currently receiving testosterone replacement therapy or have a history of insufficient
             response to testosterone replacement therapy for ejaculatory dysfunction symptoms

          -  Currently receiving treatment with cancer chemotherapy or antiandrogens

          -  History of use of estrogenizing agents

          -  Current use of warfarin

          -  History of selective serotonin reuptake inhibitor (SSRI) and/or
             serotonin-norepinephrine reuptake inhibitor (SNRI) treatment in the 6 months prior to
             screening

          -  History of frequent opioid use within 30 days prior to screening, with exception of
             treatment for chronic pain as determined by investigator.

          -  Body Mass Index (BMI) >35 kilograms per square meter (kg/m^2) at screening

          -  Significant peripheral neuropathy affecting erectile, ejaculatory, or orgasmic
             function

          -  Hematocrit ≥50% at screening

          -  Exhibit systolic blood pressure >170 millimeters of mercury (mm Hg) or <90 mm Hg or
             diastolic blood pressure >100 mm Hg or <50 mm Hg at screening (if stress is suspected,
             retest under basal conditions at screening), or have history of malignant hypertension

          -  History of any of the following coronary conditions within 90 days of screening:
             myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary
             intervention (for example, angioplasty or stent placement)

          -  Known or suspected carcinoma (or history of carcinoma) of the prostate or suspicious
             nodules on digital rectal exam at screening

          -  Known or suspected breast cancer (or history of breast cancer) or other active cancer
             (with the exception of nonmelanotic skin cancer)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 26 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