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

NCT00857961 | Completed Phase 2 Results

• 3 other identifiers: 14271MTE07I5E-MC-TSAG
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hypogonadism

Outcome Measures

Primary Outcomes (6)

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

  Tmax is the time at which the maximum concentration (Cmax) was attained during the 24 hour period on Day 7.

  Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment

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

  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.

  Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment

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

  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.

  Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment

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

  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.

  Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment

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

  Degree of fluctuation in serum concentration calculated as ((Cmax-Cmin)/Cavg) x 100%.

  Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment

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

  Area under the serum concentration versus time curve was calculated using the linear trapezoidal rule from time 0 to 24 hours on Day 7.

  Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days)

Study Arms (4)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

Testosterone MD-Lotion DRUG

Administered Topically

Also known as: LY900011, Axiron

1.5 mL (30 mg) of 2% Testosterone MD-Lotion; 3 mL (30 mg) of 1% Testosterone MD-Lotion; 3 mL (60 mg) of 2% Testosterone MD-Lotion; 4.5 mL (90 mg) of 2% Testosterone MD-Lotion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

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

Location

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

Location

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

Location

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

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone Propionate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Testosterone; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 9, 2009
• Study Start: October 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: January 7, 2011
• Results First Posted: January 7, 2011

Record last verified: 2011-01

Locations

US (4)