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

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism

Intervention: Testosterone MD-Lotion (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-31- Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

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

Clinical Details

Official title: A Phase II, Randomised, Four-way Crossover Study to Compare the Steady State Pharmacokinetics of Testosterone Following Application of Different Testosterone Metered Dose (MD) Lotion® Formulations and Doses in Hypogonadal Men

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)

Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)

Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)

Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)

Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF)

Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]

Secondary outcome: Number of Participants With Adverse Events

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Male.

Criteria:

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

Locations and Contacts

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

Additional Information

Starting date: October 2007
Last updated: January 6, 2011

Page last updated: August 23, 2015

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