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

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withdrawn from the study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