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

Lilly

Status and phase: Completed; Phase 2

Conditions: Hypogonadism

Treatments: Drug: Testosterone MD-Lotion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00857961

MTE07 (Other Identifier)

I5E-MC-TSAG (Other Identifier)

14271

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 4 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: Testosterone MD-Lotion

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

Experimental group

Description:

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

Treatment:

Drug: Testosterone MD-Lotion

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

Experimental group

Description:

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.

Treatment:

Drug: Testosterone MD-Lotion

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

Experimental group

Description:

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.

Treatment:

Drug: Testosterone MD-Lotion