A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Methyltestosterone; Pharmaceutical Solutions; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Total testosterone level <10.4 nanomoles per liter (nmol/L) [300 nanograms per deciliter (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 nanograms per milliliter (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 kilograms per square meter (kg/m^2) at screening

• Significant peripheral neuropathy affecting erectile, ejaculatory, or orgasmic function

• Hematocrit ≥50% at screening

• Exhibit systolic blood pressure >170 millimeters of mercury (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 (for example, 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)