Clinical trial: Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism (NCT02081300)

Eligibility criteria:
Inclusion Criteria:

          1. Documented diagnosis of primary hypogonadism (congenital or acquired) or
             hypogonadotropic hypogonadism (congenital or acquired).

          2. Serum total testosterone < 300 ng/dL based on 2 consecutive blood samples

        Exclusion Criteria:

        A subject will not be eligible for study participation if he meets any of the following
        criteria.

          1. History of significant sensitivity or allergy to androgens, castor oil or product
             excipients.

          2. Clinically significant findings in the prestudy examinations.

          3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS
             score > 19 points.

          4. Body mass index (BMI) ≥ 38 kg/m2.

          5. Clinically significant abnormal laboratory values

          6. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B
             surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human
             immunodeficiency virus antibodies (HIV Ab).

          7. History of seizures or convulsions, including febrile, alcohol or drug withdrawal
             seizures.

          8. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical
             procedure that might interfere with gastrointestinal motility, pH or absorption.

          9. History of any clinically significant illness, infection, or surgical procedure within
             1 month prior to study drug administration.

         10. History of stroke or myocardial infarction within the past 5 years.

         11. History of, or current or suspected, prostate or breast cancer.

         12. History of diagnosed, severe, untreated, obstructive sleep apnea.

         13. History of abuse of alcohol or any drug substance in the opinion of the investigator
             within the previous 2 years.

         14. History of long QT syndrome or unexplained sudden death in a first degree relative
             (parent, sibling, or child).

         15. Concurrent treatment with medications which may impact the absorption, distribution,
             metabolism or excretion of testosterone undecanoate (TU) or place the subject at risk
             for treatment with testosterone.

         16. Subject has a partner who is currently pregnant or planning pregnancy during the
             course of the clinical trial.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 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? Entailment