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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00857454

Enrollment

Registered

2009-03-06

Start date

2008-10-31

Completion date

2009-08-31

Last updated

2011-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

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.

Interventions

DRUGTestosterone MD-Lotion

30 mg to 120 mg administered topically once daily for 60 days

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline MTE08 to MTE09 Endpoint in Draize Score	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

Measure	Time frame
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 Fasting Insulin	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
Change From Baseline MTE08 to MTE09 Follow-up in Estradiol	Day 1, up to Day 190

Countries

United States

Participant flow

Recruitment details

This was an open-label extension to the MTE08 trial. Only participants in the MTE08 trial who consented and met eligibility criteria could be enrolled in MTE09.

Pre-assignment details

Participants received 3.0 mL (60 mg) of 2% Testosterone MD-Lotion for 60 days, and may have had their dose adjusted upwards or downwards (Subjects in MTE09 were continued on the dose that they were taking at the conclusion of study MTE08. A total of 2 patients received 30 mg; 49 remained on 60 mg, 12 received 90 mg; and 8 received 120 mg).

Participants by arm

Arm	Count
Testosterone MD-lotion 30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days	71
Total	71

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	2
Overall Study	Lost to Follow-up	1
Overall Study	MTE09 enrollment criteria not met	6
Overall Study	Total Testosterone >1050 ng/dL	1
Overall Study	Total Testosterone <300 ng/dL	8
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Testosterone MD-lotion
Age Continuous	52.3 years STANDARD_DEVIATION 12.13
Baseline Total Testosterone Level	217.93 nanograms per deciliter (ng/dL) STANDARD_DEVIATION 84.7
Body Mass Index (BMI)	29.78 kilograms per square metter (kg/m^2) STANDARD_DEVIATION 3.61
Race/Ethnicity, Customized African American	6 participants
Race/Ethnicity, Customized Caucasian	54 participants
Race/Ethnicity, Customized Hispanic	10 participants
Race/Ethnicity, Customized Other	1 participants
Region of Enrollment United States	71 participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	71 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	22 / 71
serious Total, serious adverse events	2 / 71

Outcome results

Primary

Change From Baseline MTE08 to MTE09 Endpoint in Draize Score

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.

Time frame: Day 1, Day 190

Population: Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at MTE09 endpoint (Day 190).

Arm	Measure	Value (MEAN)	Dispersion
Testosterone MD-lotion	Change From Baseline MTE08 to MTE09 Endpoint in Draize Score	0.0 units on a scale	Standard Deviation 0.12

Secondary