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

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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

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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