A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations

Eli Lilly and Company71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypogonadism

Interventions

Testosterone MD-LotionDRUG

30 mg to 120 mg administered topically once daily for 60 days

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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 Forms; were willing to follow the Protocol requirements and comply with Protocol restrictions and procedures Exclusion Criteria: * Any clinically significant chronic illness or finding and/or laboratory testing that would interfere with the trial objectives or safety of the subject * Any man in whom testosterone therapy was contraindicated, which included those with: * Known or suspected carcinoma (or history of carcinoma) of the prostate or clinically significant symptoms of benign prostatic hyperplasia and/or clinically significant symptoms of lower urinary obstructions and with a International Prostate Symptoms Score (IPSS) score of greater than or equal to 19 * Known or suspected carcinoma (or history of carcinoma) of the breast * Severe liver disease (i.e. cirrhosis, hepatitis or liver tumours or liver function tests \>2 times the upper limit of the normal range values * Active deep vein thrombosis, thromboembolic disorders or a documented history of these conditions * Current significant cerebrovascular or coronary artery disease * Untreated sleep apnoea * Haematocrit of \>54% * Untreated moderate to severe depression * Men with clinically significant prostate exam or clinically significant elevated serum Prostate Specific Antigen (PSA) level (\> 4 ng/mL) or age adjusted reference range of PSA values * Men taking concomitant medications (prescribed, over-the-counter or complementary) that would affect Sex Hormone Binding Globulin (SHBG) or testosterone concentrations (excluding Testosterone MD-Lotion (cutaneous solution)) or metabolism such as warfarin, insulin, opiates, gonadotropin-releasing hormone analogues (GnRH), 5 alpha reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for physiological replacement doses), estradiol * Men with uncontrolled diabetes (Hemoglobin A1c \[HbA1c\] greater than or equal to 10%) * Subjects intending to have any surgical procedure during the course of the trial * Subjects with a partner of child bearing potential who are not willing to use adequate contraception for the duration of the trial * Subjects whose partners are pregnant

Locations (11)

Outcomes

Primary Outcomes

Change From Baseline MTE08 to MTE09 Endpoint in Draize Score

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.

Time frame: Day 1, Day 190