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| ID | Type | Description | Link |
|---|---|---|---|
| MTE07 | Other Identifier | Acrux | |
| I5E-MC-TSAG | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone MD-Lotion | Drug | Administered Topically |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | A listing of adverse events is located in the Reported Adverse Events module. | Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days) |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone MD-Lotion | Applied once daily for 7 days. All study participants received each of the 4 study treatments: 3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla). 1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla. 3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla). 4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone MD-Lotion | Applied once daily for 7 days. All study participants received each of the 4 study treatments: 3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla). 1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla. 3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla). 4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants received all four doses of testosterone MD-lotion. | Posted | Median | Full Range | hours (h) | Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3 mL (30 mg) of 1% Testosterone MD-Lotion | Applied once daily for 7 days to both axilla (1.5 mL to each axilla). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D043343 | Testosterone Propionate |
| ID | Term |
|---|---|
| D013739 | Testosterone |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
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|
| 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 |
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms/square meter (kg/m^2) |
|
| Average Baseline Testosterone | Mean | Standard Deviation | nanograms per deciliter (ng/dL) |
|
| OG002 | 3 mL (60 mg) of 2% Testosterone MD-Lotion | Applied once daily for 7 days to both axilla (1.5 mL to each axilla). |
| OG003 | 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla). |
|
|
| Primary | 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. | All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected. | Posted | Mean | Standard Deviation | ng/dL | Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment |
|
|
|
| Primary | 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. | All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected. | Posted | Mean | Standard Deviation | ng/dL | Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment |
|
|
|
| Primary | 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. | All participants received all four doses of testosterone MD-lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected. | Posted | Mean | Standard Deviation | ng/dL | Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment |
|
|
|
| Primary | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF) | Degree of fluctuation in serum concentration calculated as ((Cmax-Cmin)/Cavg) x 100%. | All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected. | Posted | Mean | Standard Deviation | percent fluctuation in concentration | Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment |
|
|
|
| Primary | 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. | All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected. | Posted | Mean | Standard Deviation | h*ng/dL | Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment |
|
|
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| Secondary | Number of Participants With Adverse Events | A listing of adverse events is located in the Reported Adverse Events module. | All participants received all four doses of testosterone-MD lotion. | Posted | Number | participants | Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days) |
|
|
|
| 0 |
| 21 |
| 4 |
| 21 |
| EG001 | 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Applied once daily for 7 days to one axilla. | 0 | 21 | 5 | 21 |
| EG002 | 3 mL (60 mg) of 2% Testosterone MD-Lotion | Applied once daily for 7 days to both axilla (1.5 mL to each axilla). | 0 | 21 | 6 | 21 |
| EG003 | 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla). | 0 | 21 | 5 | 21 |
| Catheter site inflammation | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Chest pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
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| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Cmin |
|
| Cavg (n=21, n=20, n=21, n=21) |
|
| Cmin |
|
| Cavg (n=21, n=20, n=21, n=21) |
|
| Cmin |
|
| Cavg n=21, n=20, n=21, n=21) |
|
| Dihydrotestosterone |
|
| Free Testosterone |
|
| Dihydrotestosterone |
|
| Free Testosterone |
|
| Non-Serious Adverse Events |
|