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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Change From Baseline MTE08 to MTE09 Endpoint in Draize Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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: Testosterone MD-Lotion (Drug)
Outcomes
Primary Outcomes
Change From Baseline MTE08 to MTE09 Endpoint in Draize Score
Time Frame: 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 Outcomes
- 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)