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

Condition(s) targeted: Hypogonadism

Intervention: Testosterone MD-Lotion (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

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.

Official title: A Phase III Open-label Extension of the MTE08 Trial (A Phase III Open-label Titration Trial to Evaluate the Effectiveness and Safety of Different Doses of a Dermal Application of Testosterone MD-Lotion® (Cutaneous Solution) in Hypogonadal Men) to Evaluate Skin-safety

Study design: Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline MTE08 to MTE09 Endpoint in Draize Score

Secondary outcome:

Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin

Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose

Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA)

Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)

Change From Baseline MTE08 to MTE09 Follow-up in Estradiol

Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin

Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

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., Birmingham, Alabama, 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., Tuscon, Arizona, 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., Burbank, California, 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., Colorado Springs, Colorado, 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., New Britain,, Connecticut, 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., Ocala, Florida, 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., Boise, Idaho, 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., Shawnee Mission, Kansas, 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., Shreveport, Louisiana, 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., Omaha, Nebraska, 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

Starting date: October 2008
Last updated: December 15, 2010