Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00857454 | A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations | PHASE3 | COMPLETED | 71 | — | — | Oct 1, 2008 | Aug 1, 2009 | Jan 5, 2011 | 11 | United States |
| NCT00702650 | A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations | PHASE3 | COMPLETED | 155 | — | — | Jun 1, 2008 | Jul 1, 2009 | Jul 25, 2011 | 27 | United States, Australia +4 |
| NCT00857961 | A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations | PHASE2 | COMPLETED | 21 | — | — | Oct 1, 2007 | Jan 1, 2008 | Jan 7, 2011 | 4 | United States |
Draize score is a measurement of skin irritability of the application site based on erythema/escar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema \[beet redness\] to slight eschar formation \[injuries in depth\]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema \[raised more than 1 millimeter and extending beyond area of exposure\]. The total Draize score ranges from 0 to 8.
Cavg(0-24) is the average serum concentration calculated over the 24 hour period on Day 120. Calculated as the AUC(0-24) divided by 24 hours. Normal range for Total Testosterone was defined as 300 - 1050 nanograms per deciliter (ng/dL).
Tmax is the time at which the maximum concentration (Cmax) was attained during the 24 hour period on Day 7.
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.
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.
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.
Degree of fluctuation in serum concentration calculated as ((Cmax-Cmin)/Cavg) x 100%.
Area under the serum concentration versus time curve was calculated using the linear trapezoidal rule from time 0 to 24 hours on Day 7.
| Arm | Type | Description |
|---|---|---|
| Testosterone MD-lotion | EXPERIMENTAL | In this open-label extension of the MTE08 trial, participants received Testosterone Metered Dose (MD)-Lotion for 60 days (dosing from Day 121 of the MTE08 trial to Day 180 of the MTE09 trial). Participants in MTE08 initially received 3.0 milliliters (mL) (60 micrograms \[mg\]) of 2% Testosterone MD-Lotion, and may have had their dose of testosterone adjusted upwards or downwards. Doses could be titrated to one of the following: 1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied daily by 2 doses to the axilla (1.5 mL to one axilla). 3.0 mL (60 mg)of 2% Testosterone MD-Lotion applied daily by 2 doses to the axilla (1.5 mL to each axilla). 4.5 mL (90 mg)of 2% Testosterone MD-Lotion applied daily by 3 doses to the axilla (2 x 1.5 mL to one axilla and 2 x 1.5 mL to the other axilla). 6.0 (120 mg)of 2% Testosterone MD-Lotion applied daily by 4 doses to the axilla (2 x 1.5 mL to each axilla). |
| 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 |
|---|---|---|
| Testosterone MD-Lotion | DRUG | 30 mg to 120 mg administered topically once daily for 60 days |
Inclusion Criteria: * Hypogonadal males with a qualifying general medical health who have Completed the MTE08 trial up to and including Day 120/121 in a compliant manner * Were able to communicate with the trial staff, understand the Trial Information Sheet and sign the Written Informed Consent For...