Conditions: Hypogonadism
Allocation:  | Intervention model: PARALLEL
Enrollment: 71
Healthy volunteers: no

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 assess the occurrence of skin safety events for a further two months of continuous use of the Testosterone MD-Lotion® (cutaneous solution) after completion of the MTE08 (NCT00702650) trial.

Detailed description:

Arms:
arm 1: 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).

Interventions: intervention 1: Testosterone MD-Lotion
Intervention descriptions: intervention 1: 30 mg to 120 mg administered topically once daily for 60 days

Protocol document: