Status:
COMPLETED
A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations
Lead Sponsor:
Eli Lilly and Company
Conditions:
Hypogonadism
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will assess ...
Eligibility Criteria
Inclusion
- Hypogonadal males with a qualifying general medical health who have Completed the MTE08 trial up to and including Day 120/121 in a compliant manner
- Were able to communicate with the trial staff, understand the Trial Information Sheet and sign the Written Informed Consent Forms; were willing to follow the Protocol requirements and comply with Protocol restrictions and procedures
Exclusion
- Any clinically significant chronic illness or finding and/or laboratory testing that would interfere with the trial objectives or safety of the subject
- Any man in whom testosterone therapy was contraindicated, which included those with:
- Known or suspected carcinoma (or history of carcinoma) of the prostate or clinically significant symptoms of benign prostatic hyperplasia and/or clinically significant symptoms of lower urinary obstructions and with a International Prostate Symptoms Score (IPSS) score of greater than or equal to 19
- Known or suspected carcinoma (or history of carcinoma) of the breast
- Severe liver disease (i.e. cirrhosis, hepatitis or liver tumours or liver function tests \>2 times the upper limit of the normal range values
- Active deep vein thrombosis, thromboembolic disorders or a documented history of these conditions
- Current significant cerebrovascular or coronary artery disease
- Untreated sleep apnoea
- Haematocrit of \>54%
- Untreated moderate to severe depression
- Men with clinically significant prostate exam or clinically significant elevated serum Prostate Specific Antigen (PSA) level (\> 4 ng/mL) or age adjusted reference range of PSA values
- Men taking concomitant medications (prescribed, over-the-counter or complementary) that would affect Sex Hormone Binding Globulin (SHBG) or testosterone concentrations (excluding Testosterone MD-Lotion (cutaneous solution)) or metabolism such as warfarin, insulin, opiates, gonadotropin-releasing hormone analogues (GnRH), 5 alpha reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for physiological replacement doses), estradiol
- Men with uncontrolled diabetes (Hemoglobin A1c \[HbA1c\] greater than or equal to 10%)
- Subjects intending to have any surgical procedure during the course of the trial
- Subjects with a partner of child bearing potential who are not willing to use adequate contraception for the duration of the trial
- Subjects whose partners are pregnant
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00857454
Start Date
October 1 2008
End Date
August 1 2009
Last Update
January 5 2011
Active Locations (11)
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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.
Birmingham, Alabama, United States
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.
Tuscon, Arizona, United States
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.
Burbank, California, United States
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.
Colorado Springs, Colorado, United States