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

Lilly

Status and phase: Completed; Phase 3

Conditions: Hypogonadism

Treatments: Drug: Testosterone MD-Lotion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00857454

MTE09 (Other Identifier)

I5E-MC-TSAI (Other Identifier)

14273

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

71 participants in 1 patient group

Testosterone MD-lotion

Experimental group

Description:

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:

Drug: Testosterone MD-Lotion