Phase 3
Completed N=71
A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations
Source: ClinicalTrials.gov NCT00857454 ↗Enrolled (actual)
71
Serious AEs
2.8%
Results posted
Jan 2011
Primary outcomePrimary: Change From Baseline MTE08 to MTE09 Endpoint in Draize Score — 0.0 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline MTE08 to MTE09 Endpoint in Draize Score |
0.0 | — |
| SECONDARY Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin |
1.43 | — |
| SECONDARY Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose |
12.25 | — |
| SECONDARY Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA) |
0.10 | — |
| SECONDARY Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) |
-1.39; -1.82 | — |
| SECONDARY Change From Baseline MTE08 to MTE09 Follow-up in Estradiol |
2.76 | — |
| SECONDARY Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin |
0.54 | — |
| SECONDARY Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit |
0.03 | — |
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
Data sourced from ClinicalTrials.gov (NCT00857454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.