A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels

Lilly

Status and phase: Completed; Phase 2

Conditions: Ejaculatory Dysfunction; Hypogonadism

Treatments: Drug: Placebo Solution; Drug: Testosterone Solution 2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01419236

I5E-MC-TSAB (Other Identifier)

13981

Details and patient eligibility

About

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

Enrollment: 76 patients

Sex: Male

Ages: 26+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 2 patient groups, including a placebo group

Testosterone Solution 2% 60 milligrams (mg)

Experimental group

Description:

Testosterone Solution 2% 60 mg applied topically once daily with possible 1-time titration to 30 milligrams per day (mg/day) or 90 mg/day for 16 weeks

Treatment:

Drug: Testosterone Solution 2%

Placebo

Placebo Comparator group

Description:

Placebo solution applied topically once daily for 16 weeks

Treatment:

Drug: Placebo Solution