The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Topical Testosterone Solution
Intervention description: Administered topically to axillae.
Intervention MeSH terms: Methyltestosterone; Pharmaceutical Solutions; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate if testosterone solution can raise testosterone hormone levels into
      the normal range after treatment for up to 9 Weeks, in those participants with a documented
      history of subtherapeutic levels [total testosterone <300 nanograms per deciliter (ng/dL)]
      when previously treated with a topical testosterone gel.
    

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