Clinical trial NCT00857454: A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypogonadism
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 71
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline MTE08 to MTE09 Endpoint in Draize Score
timeFrame: Day 1, Day 190
Secondary outcomes:
measure: Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin
timeFrame: Day 1, up to Day 190
measure: Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose
timeFrame: Day 1, up to Day 190
measure: Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA)
timeFrame: Day 1, up to Day 190
measure: Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
timeFrame: Day 1, up to Day 190
measure: Change From Baseline MTE08 to MTE09 Follow-up in Estradiol
timeFrame: Day 1, up to Day 190
measure: Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin
timeFrame: Day 1, up to Day 190
measure: Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit
timeFrame: Day 1, up to Day 190
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 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.
state: Alabama
city: Tuscon
country: United States
facility: 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.
state: Arizona
city: Burbank
country: United States
facility: 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.
state: California
city: Colorado Springs
country: United States
facility: 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.
state: Colorado
city: New Britain,
country: United States
facility: 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.
state: Connecticut
city: Ocala
country: United States
facility: 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.
state: Florida
city: Boise
country: United States
facility: 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.
state: Idaho
city: Shawnee Mission
country: United States
facility: 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.
state: Kansas
city: Shreveport
country: United States
facility: 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.
state: Louisiana
city: Omaha
country: United States
facility: 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.
state: Nebraska
city: San Antonio
country: United States
facility: 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.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: