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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00857454
First received: March 4, 2009
Last updated: December 15, 2010
Last verified: December 2010

March 4, 2009
December 15, 2010
October 2008
August 2009   (final data collection date for primary outcome measure)
Change From Baseline MTE08 to MTE09 Endpoint in Draize Score [ Time Frame: Day 1, Day 190 ] [ Designated as safety issue: No ]
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.
Change in Draize Score (from Day 1 to Day 180) for the duration of six months of continuous use of Investigational Product. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00857454 on ClinicalTrials.gov Archive Site
  • Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin [ Time Frame: Day 1, up to Day 190 ] [ Designated as safety issue: No ]
  • Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose [ Time Frame: Day 1, up to Day 190 ] [ Designated as safety issue: No ]
  • Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA) [ Time Frame: Day 1, up to Day 190 ] [ Designated as safety issue: No ]
  • Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) [ Time Frame: Day 1, up to Day 190 ] [ Designated as safety issue: No ]
  • Change From Baseline MTE08 to MTE09 Follow-up in Estradiol [ Time Frame: Day 1, up to Day 190 ] [ Designated as safety issue: No ]
  • Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin [ Time Frame: Day 1, up to Day 190 ] [ Designated as safety issue: No ]
  • Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit [ Time Frame: Day 1, up to Day 190 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypogonadism
Drug: Testosterone MD-Lotion
30 mg to 120 mg administered topically once daily for 60 days
Other Names:
  • LY900011
  • Axiron
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).

Intervention: Drug: Testosterone MD-Lotion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00857454
14273, MTE09, I5E-MC-TSAI
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP