A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations

Completed · Phase 2

Conditions studied: Hypogonadism

In brief

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 evaluate pharmacokinetics of testosterone MD-Lotion formulations.The study will also assess safety of the product.

Key facts

Study ID

NCT00857961

Run by

Eli Lilly and Company

People needed

21

Starts

2007-10-01

Expected to finish

2008-01-01

Last updated by the study team

2011-01-07

Who can join

Age: 18 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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
• 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
• 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

Full record on ClinicalTrials.gov

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