Status:
COMPLETED
A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations
Lead Sponsor:
Eli Lilly and Company
Conditions:
Hypogonadism
Eligibility:
MALE
18+ years
Phase:
PHASE3
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 (cutaneous solution), and t...
Eligibility Criteria
Inclusion
- Male subjects with a prior documented definitive diagnosis of hypogonadism as evidenced by previously documented:
- Hypothalamic, pituitary or testicular disorder or age related idiopathic hypogonadism
- Screening serum testosterone of less than or equal to 300 ng/dL (based on the average of two morning samples taken at least 30 minutes apart)
- Were currently receiving treatment for hypogonadism in accordance with approved labelling, or in the Investigator's opinion are eligible to receive such treatment
- Body Mass Index (BMI) \< 35.0 kg/m\^2
- Haemoglobin levels at screening greater than or equal to 11.5 g/dL
- Adequate venous access on left or right arm to allow collection of a number of samples by venipuncture
- Ability to communicate with the trial staff, understand the Trial Information Sheet and sign the Written Informed Consent Forms; willing to follow the Protocol requirements and comply with Protocol restrictions and procedures
Exclusion
- Current use of long acting testosterone injectables such as Nebido®
- Any significant history of allergy and/or sensitivity to the drug products or their excipients, including any history of sensitivity to testosterone and/or sunscreens
- Any clinically significant chronic illness or finding on screening physical exam and/or laboratory testing that makes it undesirable for the Investigator to enrol the trial subject in the trial and/or that in the Investigator's opinion, would interfere with the trial objectives or safety of the subject
- Chronic skin disorder (e.g. eczema, psoriasis) likely to interfere with transdermal drug absorption
- Men with suspected reversible hypogonadism
- 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 obstruction and International Prostate Symptom Scores (IPSS) scores 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 \> 51
- Untreated moderate to severe depression
- Men with clinically significant prostate exam (such as irregularities or nodules palpated) or clinically significant elevated serum Prostate Specific Antigen (PSA) levels (\>4 ng/mL), or age adjusted reference range of PSA values
- Current or history of drug or alcohol abuse (more than 4 standard drinks per day and/or abnormal liver function tests \>2 times the upper limit of the normal range values)
- Men taking concomitant medications (prescribed, over-the-counter or complementary) that would affect sex hormone binding globulin (SHBG) or testosterone concentrations or metabolism, warfarin, insulin, opiates, Gonadotropin-releasing hormone (GnRH), 5 alpha reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for physiological replacement doses), estradiol
- Men involved in sport in which there is screening for anabolic steroids
- Men with uncontrolled diabetes (haemoglobin A1c \[HbA1c\] greater than or equal to 10%)
- Men currently taking any investigational product, or have received an investigational product within 28 days prior to screening or 5 half-lives
- Any contraindication to blood sampling
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00702650
Start Date
June 1 2008
End Date
July 1 2009
Last Update
July 25 2011
Active Locations (27)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Birmingham, Alabama, United States
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tuscon, Arizona, United States
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Burbank, California, United States
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Torrance, California, United States