A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels

• Change from Baseline in Ejaculate Volume at 16 Weeks [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Sexual Activity Log at 16 Weeks [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in the International Index of Erectile Function-Orgasmic Function Domain Score at 16 Weeks [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in MSHQ-EjD-SF Bother/Satisfaction Score at 16 Weeks [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]

The purpose of this study is to see if testosterone solution 2% can help symptoms of ejaculatory dysfunction in men with low testosterone.

• Ejaculatory Dysfunction
• Hypogonadism

• Drug: Testosterone Solution 2%
  Administered topically
  Other Names:

  • Axiron
  • LY900011
• Drug: Placebo Solution
  Administered topically

• Experimental: Testosterone Solution 2% 60 mg
  Testosterone Solution 2% 60 mg applied topically once daily with possible 1-time titration to 30 mg/day or 90 mg/day for 16 weeks
  Intervention: Drug: Testosterone Solution 2%
• Placebo Comparator: Placebo
  Placebo solution applied topically once daily for 16 weeks
  Intervention: Drug: Placebo Solution

Inclusion Criteria:

• Total testosterone level <10.4 nmol/L (300 ng/dL) at screening
• Presents with 1 or more of the following symptom(s) of ejaculatory dysfunction: delayed ejaculation, anejaculation, decreased force of ejaculation, or decreased ejaculatory volume, as determined by investigator assessment
• Prostate-Specific Antigen (PSA) <4 ng/mL at screening

Exclusion Criteria:

• Sexual partner who is or becomes pregnant at any time during the study
• Premature ejaculation as determined by investigator assessment
• Currently receiving testosterone replacement therapy or have a history of insufficient response to testosterone replacement therapy for ejaculatory dysfunction symptoms
• Currently receiving treatment with cancer chemotherapy or antiandrogens
• History of use of estrogenizing agents
• Current use of warfarin
• History of selective serotonin reuptake inhibitor (SSRI) and/or serotonin-norepinephrine reuptake inhibitor (SNRI) treatment in the 6 months prior to screening
• History of frequent opioid use within 30 days prior to screening, with exception of treatment for chronic pain as determined by investigator.
• Body Mass Index (BMI) >35 kg/m2 at screening
• Significant peripheral neuropathy affecting erectile, ejaculatory, or orgasmic function
• Hematocrit ≥50% at screening
• Exhibit systolic blood pressure >170 mm Hg or <90 mm Hg or diastolic blood pressure >100 mm Hg or <50 mm Hg at screening (if stress is suspected, retest under basal conditions at screening), or have history of malignant hypertension
• History of any of the following coronary conditions within 90 days of screening: Myocardial infarction, Coronary artery bypass graft surgery, Percutaneous coronary intervention (eg, angioplasty or stent placement)
• 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) or other active cancer (with the exception of nonmelanotic skin cancer)