A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels
Status: | Completed |
---|---|
Conditions: | Endocrine |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 26 - Any |
Updated: | 10/19/2013 |
Start Date: | August 2011 |
End Date: | December 2013 |
Contact: | There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or |
Phone: | 1-317-615-4559 |
A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Explore the Impact of Testosterone Solution 2% on Symptoms of Ejaculatory Dysfunction in Men With Testosterone Deficiency
The purpose of this study is to see if testosterone solution 2% can help symptoms of
ejaculatory dysfunction in men with low testosterone.
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)
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