Status:
COMPLETED
A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations
Lead Sponsor:
Eli Lilly and Company
Conditions:
Hypogonadism
Eligibility:
MALE
18-70 years
Phase:
PHASE2
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 evaluat...
Eligibility Criteria
Inclusion
- Male study participants with a prior documented diagnosis of hypoandrogenism as evidenced by previously documented: Hypothalamic, pituitary or testicular disorder or a Serum testosterone less than or equal to 300 ng/dL
- Were receiving, or in the investigator's opinion were eligible to receive treatment for hypoandrogenism
- Body Mass Index (BMI) less than 35 kg/m\^2
- Passed the required laboratory and physical screening tests
- Haemoglobin levels at screening greater than or equal to 13.0 g/dL
- Adequate venous access on left or right arm
- Able to communicate with study staff, understand the study information sheet and sign the written Informed Consent forms; willing to follow and comply with study procedures
Exclusion
- Any significant history of allergy and/or sensitivity to the drug products or their excipients, including any history of sensitivity to testosterone and/or sunscreens
- Any clinically significant chronic illness or finding on screening physical exam and/or laboratory testing
- Chronic skin disorder (e.g. eczema, psoriasis) likely to interfere with transdermal drug absorption
- Men with suspected reversible hypoandrogenism (i.e. due to medications, stress)
- Any man in whom testosterone therapy is contraindicated, which included those with:
- Known or suspected carcinoma (or history of carcinoma) of the prostate or symptoms of benign prostatic hyperplasia and/or symptoms of lower urinary obstruction,
- Known or suspected carcinoma (or history of carcinoma) of the breast,
- Severe liver damage i.e. cirrhosis, hepatitis or liver tumours,
- Active deep vein thrombosis, thromboembolic disorders or a documented history of these conditions,
- Significant cerebrovascular or coronary artery disease,
- Known or suspected sleep apnoea,
- Hematocrit \> 51%
- Men with clinically significant prostate exam or clinically significant elevated serum prostate specific antigen (PSA) level, or age adjusted reference range of PSA values.
- Current history of drug or alcohol abuse (more than 4 standard drinks per day and/or abnormal liver function tests 3 times the upper limit of the normal range values)
- Men taking concomitant medications that affect sex hormone binding globulin (SHBG) or testosterone concentrations or metabolism, or that were cytochrome P450 inducers or inhibitors, anti-coagulants (warfarin), or diabetic medications (insulin), anti-histamines
- Men involved in sport in which there was screening for anabolic steroids
- Men with uncontrolled diabetes (hemoglobin A1c \[HbA1c\] greater than or equal to 10%)
- Men taking any Investigational Product, or who had received an Investigational Product within 28 days prior to screening or 5 half-lives (whichever was the longer)
- Any contraindication to blood sampling
- Study participants who planned to have a surgical procedure during the course of the study
- Study participants with a partner of child bearing potential who was not willing to use adequate contraception (i.e. condoms) for the duration of the study
- Study participants whose partners were pregnant
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00857961
Start Date
October 1 2007
End Date
January 1 2008
Last Update
January 7 2011
Active Locations (4)
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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.
Tuscon, Arizona, 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.
Burbank, California, 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.
New Britain, Connecticut, 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.
San Antonio, Texas, United States