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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00857454




Registration number
NCT00857454
Ethics application status
Date submitted
4/03/2009
Date registered
6/03/2009
Date last updated
5/01/2011

Titles & IDs
Public title
A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations
Scientific 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
Secondary ID [1] 0 0
MTE09
Secondary ID [2] 0 0
14273
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypogonadism 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Testosterone MD-Lotion

Experimental: 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).


Treatment: Drugs: Testosterone MD-Lotion
30 mg to 120 mg administered topically once daily for 60 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline MTE08 to MTE09 Endpoint in Draize Score
Timepoint [1] 0 0
Day 1, Day 190
Secondary outcome [1] 0 0
Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin
Timepoint [1] 0 0
Day 1, up to Day 190
Secondary outcome [2] 0 0
Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose
Timepoint [2] 0 0
Day 1, up to Day 190
Secondary outcome [3] 0 0
Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA)
Timepoint [3] 0 0
Day 1, up to Day 190
Secondary outcome [4] 0 0
Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
Timepoint [4] 0 0
Day 1, up to Day 190
Secondary outcome [5] 0 0
Change From Baseline MTE08 to MTE09 Follow-up in Estradiol
Timepoint [5] 0 0
Day 1, up to Day 190
Secondary outcome [6] 0 0
Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin
Timepoint [6] 0 0
Day 1, up to Day 190
Secondary outcome [7] 0 0
Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit
Timepoint [7] 0 0
Day 1, up to Day 190

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2009
Sample size
Target
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00857454
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00857454