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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00857961
First received: March 4, 2009
Last updated: January 6, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Hypogonadism
Drug: Testosterone MD-Lotion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax) [ Time Frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment ] [ Designated as safety issue: No ]
    Tmax is the time at which the maximum concentration (Cmax) was attained during the 24 hour period on Day 7.

  • Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) [ Time Frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment ] [ Designated as safety issue: No ]
    Cmax is the maximum observed serum concentration of total testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.

  • Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) [ Time Frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment ] [ Designated as safety issue: No ]
    Cmax is the maximum observed serum concentration of dihydrotestosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.

  • Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) [ Time Frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment ] [ Designated as safety issue: No ]
    Cmax is the maximum observed serum concentration of free testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.

  • Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF) [ Time Frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment ] [ Designated as safety issue: No ]
    Degree of fluctuation in serum concentration calculated as ((Cmax-Cmin)/Cavg) x 100%.

  • Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)] [ Time Frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment ] [ Designated as safety issue: No ]
    Area under the serum concentration versus time curve was calculated using the linear trapezoidal rule from time 0 to 24 hours on Day 7.


Secondary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days) ] [ Designated as safety issue: Yes ]
    A listing of adverse events is located in the Reported Adverse Events module.


Enrollment: 21
Study Start Date: October 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Testosterone MD-Lotion
Administered Topically
Other Names:
  • LY900011
  • Axiron
Experimental: 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.
Drug: Testosterone MD-Lotion
Administered Topically
Other Names:
  • LY900011
  • Axiron
Experimental: 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.
Drug: Testosterone MD-Lotion
Administered Topically
Other Names:
  • LY900011
  • Axiron
Experimental: 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.
Drug: Testosterone MD-Lotion
Administered Topically
Other Names:
  • LY900011
  • Axiron

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857961

Locations
United States, Arizona
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
United States, California
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
United States, Connecticut
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
United States, Texas
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-31- Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00857961     History of Changes
Other Study ID Numbers: 14271, MTE07, I5E-MC-TSAG
Study First Received: March 4, 2009
Results First Received: December 15, 2010
Last Updated: January 6, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 28, 2014