Hypogonadism
Conditions
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.
Interventions
Administered Topically
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax) | Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment | 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) | Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment | 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) | Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment | 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) | Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment | 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) | Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment | 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)] | Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days) | A listing of adverse events is located in the Reported Adverse Events module. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Testosterone MD-Lotion |
|---|---|
| Age Continuous | 47.3 years STANDARD_DEVIATION 12.3 |
| Average Baseline Testosterone | 193.2 nanograms per deciliter (ng/dL) STANDARD_DEVIATION 73.9 |
| Body Mass Index (BMI) | 30.1 kilograms/square meter (kg/m^2) STANDARD_DEVIATION 3.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 21 | 5 / 21 | 6 / 21 | 5 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 | 0 / 21 | 0 / 21 |
Outcome results
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.
Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmax | 90.7 ng/dL | Standard Deviation 64.1 |
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cavg (n=21, n=20, n=21, n=21) | 62.3 ng/dL | Standard Deviation 34 |
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmin | 33.3 ng/dL | Standard Deviation 14.4 |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmax | 69.4 ng/dL | Standard Deviation 58.6 |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cavg (n=21, n=20, n=21, n=21) | 53.0 ng/dL | Standard Deviation 45.4 |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmin | 34.6 ng/dL | Standard Deviation 26.5 |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmin | 47.8 ng/dL | Standard Deviation 29.4 |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmax | 96.4 ng/dL | Standard Deviation 46.2 |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cavg (n=21, n=20, n=21, n=21) | 71.4 ng/dL | Standard Deviation 35.1 |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmax | 98.6 ng/dL | Standard Deviation 46.1 |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cavg (n=21, n=20, n=21, n=21) | 76.5 ng/dL | Standard Deviation 35.9 |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmin | 49.4 ng/dL | Standard Deviation 26.7 |
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.
Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmax | 14.6 ng/dL | Standard Deviation 7.5 |
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cavg n=21, n=20, n=21, n=21) | 8.9 ng/dL | Standard Deviation 2.6 |
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmin | 4.4 ng/dL | Standard Deviation 1.7 |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmax | 11.3 ng/dL | Standard Deviation 5.9 |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cavg n=21, n=20, n=21, n=21) | 7.6 ng/dL | Standard Deviation 3.1 |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmin | 4.5 ng/dL | Standard Deviation 1.3 |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmin | 5.9 ng/dL | Standard Deviation 2.7 |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmax | 15.9 ng/dL | Standard Deviation 7.8 |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cavg n=21, n=20, n=21, n=21) | 10.4 ng/dL | Standard Deviation 3.9 |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmax | 16.5 ng/dL | Standard Deviation 6.2 |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cavg n=21, n=20, n=21, n=21) | 11.4 ng/dL | Standard Deviation 4.6 |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmin | 6.4 ng/dL | Standard Deviation 3.6 |
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.
Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)] | Total Testosterone | 8111 h*ng/dL | Standard Deviation 2394 |
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)] | Free Testosterone | 214 h*ng/dL | Standard Deviation 61 |
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)] | Dihydrotestosterone | 1496 h*ng/dL | Standard Deviation 816 |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)] | Total Testosterone | 7053 h*ng/dL | Standard Deviation 3594 |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)] | Free Testosterone | 183 h*ng/dL | Standard Deviation 74 |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)] | Dihydrotestosterone | 1271 h*ng/dL | Standard Deviation 1090 |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)] | Dihydrotestosterone | 1712 h*ng/dL | Standard Deviation 842 |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)] | Total Testosterone | 9332 h*ng/dL | Standard Deviation 3639 |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)] | Free Testosterone | 250 h*ng/dL | Standard Deviation 94 |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)] | Total Testosterone | 10361 h*ng/dL | Standard Deviation 4436 |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)] | Free Testosterone | 275 h*ng/dL | Standard Deviation 111 |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)] | Dihydrotestosterone | 1836 h*ng/dL | Standard Deviation 862 |
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%.
Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF) | Total Testosterone | 107 percent fluctuation in concentration | Standard Deviation 55 |
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF) | Free Testosterone | 107 percent fluctuation in concentration | Standard Deviation 55 |
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF) | Dihydrotestosterone | 85 percent fluctuation in concentration | Standard Deviation 47 |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF) | Total Testosterone | 84 percent fluctuation in concentration | Standard Deviation 34 |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF) | Free Testosterone | 84 percent fluctuation in concentration | Standard Deviation 34 |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF) | Dihydrotestosterone | 68 percent fluctuation in concentration | Standard Deviation 25 |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF) | Dihydrotestosterone | 70 percent fluctuation in concentration | Standard Deviation 29 |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF) | Total Testosterone | 91 percent fluctuation in concentration | Standard Deviation 41 |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF) | Free Testosterone | 91 percent fluctuation in concentration | Standard Deviation 41 |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF) | Total Testosterone | 92 percent fluctuation in concentration | Standard Deviation 36 |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF) | Free Testosterone | 92 percent fluctuation in concentration | Standard Deviation 36 |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF) | Dihydrotestosterone | 65 percent fluctuation in concentration | Standard Deviation 24 |
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.
Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Population: All participants received all four doses of testosterone MD-lotion.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax) | Total Testosterone | 8.00 hours (h) |
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax) | Free Testosterone | 8.00 hours (h) |
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax) | Dihydrotestosterone | 8.00 hours (h) |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax) | Total Testosterone | 12.00 hours (h) |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax) | Free Testosterone | 12.00 hours (h) |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax) | Dihydrotestosterone | 11.93 hours (h) |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax) | Dihydrotestosterone | 4.25 hours (h) |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax) | Total Testosterone | 4.25 hours (h) |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax) | Free Testosterone | 4.25 hours (h) |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax) | Total Testosterone | 15.98 hours (h) |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax) | Free Testosterone | 15.98 hours (h) |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax) | Dihydrotestosterone | 15.98 hours (h) |
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.
Time frame: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmax | 546 ng/dL | Standard Deviation 266 |
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cavg (n=21, n=20, n=21, n=21) | 338 ng/dL | Standard Deviation 100 |
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmin | 164 ng/dL | Standard Deviation 63 |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmax | 430 ng/dL | Standard Deviation 259 |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cavg (n=21, n=20, n=21, n=21) | 294 ng/dL | Standard Deviation 150 |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmin | 171 ng/dL | Standard Deviation 59 |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmin | 221 ng/dL | Standard Deviation 101 |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmax | 590 ng/dL | Standard Deviation 289 |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cavg (n=21, n=20, n=21, n=21) | 389 ng/dL | Standard Deviation 152 |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmax | 626 ng/dL | Standard Deviation 264 |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cavg (n=21, n=20, n=21, n=21) | 432 ng/dL | Standard Deviation 185 |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg) | Cmin | 238 ng/dL | Standard Deviation 135 |
Secondary
Number of Participants With Adverse Events
A listing of adverse events is located in the Reported Adverse Events module.
Time frame: Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days)
Population: All participants received all four doses of testosterone-MD lotion.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Number of Participants With Adverse Events | Non-Serious Adverse Events | 4 participants |
| 3 mL (30 mg) of 1% Testosterone MD-Lotion | Number of Participants With Adverse Events | Serious Adverse Events | 0 participants |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Number of Participants With Adverse Events | Non-Serious Adverse Events | 5 participants |
| 1.5 mL (30 mg) of 2% Testosterone MD-Lotion | Number of Participants With Adverse Events | Serious Adverse Events | 0 participants |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Number of Participants With Adverse Events | Serious Adverse Events | 0 participants |
| 3 mL (60 mg) of 2% Testosterone MD-Lotion | Number of Participants With Adverse Events | Non-Serious Adverse Events | 6 participants |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Number of Participants With Adverse Events | Serious Adverse Events | 0 participants |
| 4.5 mL (90 mg) of 2% Testosterone MD-Lotion | Number of Participants With Adverse Events | Non-Serious Adverse Events | 5 participants |