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

Phase 3

Completed

Conditions: Hypogonadism

Interventions: Drug: Testosterone MD-Lotion

Registration Number: NCT00857454

Lead Sponsor: Eli Lilly and Company

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: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 71

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testosterone MD-lotion	Testosterone MD-Lotion	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).

Primary Outcome Measures

Name	Time	Method
Change From Baseline MTE08 to MTE09 Endpoint in Draize Score	Day 1, Day 190	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin	Day 1, up to Day 190
Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose	Day 1, up to Day 190
Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA)	Day 1, up to Day 190
Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)	Day 1, up to Day 190
Change From Baseline MTE08 to MTE09 Follow-up in Estradiol	Day 1, up to Day 190
Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin	Day 1, up to Day 190
Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit	Day 1, up to Day 190

Trial Locations

Locations (1): 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
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