Status:
COMPLETED
A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels
Lead Sponsor:
Eli Lilly and Company
Conditions:
Ejaculatory Dysfunction
Hypogonadism
Eligibility:
MALE
26+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if testosterone solution 2% can impact symptoms of ejaculatory dysfunction in men with low testosterone.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01419236
Start Date
August 1 2011
End Date
December 1 2013
Last Update
December 19 2014
Active Locations (7)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California, United States, 90048
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Diego, California, United States, 92120
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
New Orleans, Louisiana, United States, 70112
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brookline, Massachusetts, United States, 02445