Conditions

Hypogonadism

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Achieving Normal Serum Testosterone Levels
Normal serum testosterone level is defined as ≥300 to ≤1050 nanograms/deciliter (ng/dL). Serum testosterone levels were measured by liquid chromatography and tandem mass spectrometry (LC/MS-MS). Percentage of participants = (number of participants who achieved normal serum testosterone level) / (number of treated participants who had serum testosterone level measured) \* 100.
Baseline through Study Completion (Up to 9 Weeks)

Secondary Outcomes (3)

Change From Baseline in Serum Testosterone Levels
Baseline, Study Completion (Up to 9 Weeks)
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Study Days 15, 22, 36, 43, 57, 64 and endpoint
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Study Days 15, 22, 36, 43, 57, 64 and endpoint

Study Arms (1)

Topical Testosterone Solution

EXPERIMENTAL

Topical Testosterone Solution 30 milligrams up to 120 milligrams per day (mg/day) administered topically to axillae titrated based on testosterone levels.

Drug: Topical Testosterone Solution

Interventions

Topical Testosterone SolutionDRUG

Administered topically to axillae.

Also known as: LY900011, Axiron, Testosterone Solution 2%

Topical Testosterone Solution

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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
+2 more criteria

Contact the study team to confirm eligibility.