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

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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)

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

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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