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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypogonadism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3 mL (30 mg) of 1% Testosterone MD-Lotion

Applied once daily for 7 days to both axilla (1.5 mL to each axilla). All study participants are randomized to each of the 4 study treatments.

Group Type EXPERIMENTAL

Testosterone MD-Lotion

Intervention Type DRUG

Administered Topically

1.5 mL (30 mg) of 2% Testosterone MD-Lotion

Applied once daily for 7 days to one axilla. All study participants are randomized to each of the 4 study treatments.

Group Type EXPERIMENTAL

Testosterone MD-Lotion

Intervention Type DRUG

Administered Topically

3 mL (60 mg) of 2% Testosterone MD-Lotion

Applied once daily for 7 days to both axilla (1.5 mL to each axilla). All study participants are randomized to each of the 4 study treatments.

Group Type EXPERIMENTAL

Testosterone MD-Lotion

Intervention Type DRUG

Administered Topically

4.5 mL (90 mg) of 2% Testosterone MD-Lotion

Applied once daily for 7 days by three doses to both axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla). All study participants are randomized to each of the 4 study treatments.

Group Type EXPERIMENTAL

Testosterone MD-Lotion

Intervention Type DRUG

Administered Topically

Interventions

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Testosterone MD-Lotion

Administered Topically

Intervention Type DRUG

Other Intervention Names

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LY900011 Axiron

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No