Clinical trial: The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel (NCT01893281)

Eligibility criteria:
Inclusion Criteria:

          -  Able to read, understand, and provide signed informed consent before starting trial
             activities related to this study (including discontinuing testosterone replacement
             therapy prior to Screening)

          -  Male participants with a diagnosis of hypogonadism and documented biochemical failure
             (total testosterone <300 ng/dL) when treated with the highest dose of a topical
             testosterone gel tolerated by the participant. Documentation of biochemical failure
             includes: the name and dose of the topical testosterone gel, a lab report showing a
             total testosterone level <300 ng/dL while on therapy, or a written chart report
             stating that there was a clear lack of efficacy, including the participant's serum
             total testosterone level at the time of failure

          -  Screening serum total testosterone level of <300 ng/dL (based on the average of 2
             morning blood samples taken at least 30 minutes apart) at Screening

          -  Prostate Specific Antigen (PSA) <4 nanogram per milliliter (ng/mL) at Screening

          -  If the participant is receiving testosterone replacement therapy and is willing to
             discontinue testosterone replacement therapy to enter the study, their screening total
             testosterone level cannot be checked until at least 14 days after discontinuing
             topical therapies, or after at least 28 days for participants using short-acting
             intramuscular (IM) therapies

        Exclusion Criteria:

          -  Any previous treatment with testosterone topical solution (LY900011)

          -  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

          -  Severe sleep apnea (untreated or unsuccessfully treated) in the opinion of the study
             investigator

          -  Use of long-acting IM testosterone undecanoate in the 6-month period prior to
             Screening

          -  History of the use of an implanted testosterone pellets (Testopel)

          -  International Prostate Symptom Score (IPSS) total score >19 at Screening

          -  Hematocrit ≥50% at Screening. For sites located at elevations ≥4500 feet, participants
             will be excluded with hematocrit >54% according to investigator discretion. Any
             participant with a hematocrit >54% at later study visits will be withdrawn from the
             study

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

          -  Dermatologic condition in underarm area that might interfere with testosterone
             absorption (for example, eczema) or that could be exacerbated by topical testosterone
             replacement therapy

          -  History of luteinizing hormone-releasing hormone (LHRH) antagonist or agonist
             treatment in the 6 months prior to Screening

          -  Exhibit any evidence of congestive heart failure [New York Heart Association (NYHA)
             Class 2 or above] within 6 months prior to Screening

          -  Exhibit evidence of severe renal impairment [creatinine clearance <30 milliliter per
             minute (mL/min) as determined by the Cockcroft-Gault formula] at Screening

          -  Exhibit a history of severe liver disease or clinical evidence of hepatic impairment
             at Screening

          -  Any condition that would interfere with the participant's ability to provide informed
             consent, or comply with study instructions, or would place the participant at
             increased risk, or might confound the interpretation of the study results

          -  Are investigator site personnel directly affiliated with this study and/or their
             immediate families. Immediate family is defined as a spouse, parent, child, or
             sibling, whether biological or legally adopted

          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical
             trial involving an investigational product or non-approved use of a drug or device
             (other than the investigational product used in this study), or are concurrently
             enrolled in any other type of medical research judged not to be scientifically or
             medically compatible with this study
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