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
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