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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00702650




Registration number
NCT00702650
Ethics application status
Date submitted
19/06/2008
Date registered
20/06/2008
Date last updated
25/07/2011

Titles & IDs
Public title
A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations
Scientific title
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
Secondary ID [1] 0 0
MTE08
Secondary ID [2] 0 0
14272
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypogonadism 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Testosterone MD-Lotion

Experimental: Testosterone MD-Lotion - Participants received Testosterone Metered Dose (MD)-Lotion for 120 days. Participants started by receiving 3.0 mL (60 mg) of 2% Testosterone MD-Lotion, and based upon restoration to eugonadal levels, may have had their dose of testosterone adjusted upwards or downwards on Days 45 and 90.
Doses could be titrated to one of the following:
1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied daily by 1 dose 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 1 x 1.5 mL to the other axilla).
6.0 mL (120 mg) of 2% Testosterone MD-Lotion applied daily by 4 doses to the axilla (2 x 1.5 mL to each axilla).


Treatment: Drugs: Testosterone MD-Lotion
30 mg to 120 mg administered topically once daily for 120 days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120 - Cavg(0-24) is the average serum concentration calculated over the 24 hour period on Day 120. Calculated as the AUC(0-24) divided by 24 hours. Normal range for Total Testosterone was defined as 300 - 1050 nanograms per deciliter (ng/dL).
Timepoint [1] 0 0
Day 120
Secondary outcome [1] 0 0
Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL - Cmax is the maximum observed serum concentration (>1500 ng/dL) during the 24 hour period on Day 120.
Timepoint [1] 0 0
Day 120
Secondary outcome [2] 0 0
Percentage of Participants With Cmax Between 1800 and 2500 ng/dL - Cmax is the maximum observed serum concentration (between 1800 and 2500 ng/dL) during the 24 hour period on Day 120.
Timepoint [2] 0 0
Day 120
Secondary outcome [3] 0 0
Percentage of Participants With Cmax >2500 ng/dL - Cmax is the maximum observed serum concentration (>2500 ng/dL) during the 24 hour period on Day 120.
Timepoint [3] 0 0
Day 120
Secondary outcome [4] 0 0
Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL - Cmin is the minimum observed serum concentration (<300 ng/dL) during the 24 hour period on Day 120.
Timepoint [4] 0 0
Day 120
Secondary outcome [5] 0 0
Change From Baseline to Endpoint in Psychosexual Daily Questionnaire - Questions included: Sexual Desire (0=none to 7=very high), Overall Sexual Activity Score (calculated as average of weekly values on scale from 0=none to 7=Frequent), Erection Maintained for Satisfactory Duration (0=not satisfactory to 7=very satisfactory), and Positive and Negative Mood (individual mood variables on scale from 0=Not at all true to 7=very true). Positive mood: sum of 4 positive mood variables-alert, full of pep/energetic, friendly, and well/good (range from 0-28). Negative mood: sum of 5 negative mood variables-angry, irritable, sad/blue, tired, and nervous (range from 0-35).
Timepoint [5] 0 0
Baseline, Day 120
Secondary outcome [6] 0 0
Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36) - The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).
Timepoint [6] 0 0
Baseline, Day 120
Secondary outcome [7] 0 0
Change From Baseline to Endpoint in Fasting Insulin
Timepoint [7] 0 0
Baseline, up to Day 120
Secondary outcome [8] 0 0
Change From Baseline to Endpoint in Fasting Glucose
Timepoint [8] 0 0
Baseline, up to Day 120
Secondary outcome [9] 0 0
Change From Baseline to Endpoint in Prostate Specific Antigen (PSA)
Timepoint [9] 0 0
Baseline, Day 120
Secondary outcome [10] 0 0
Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
Timepoint [10] 0 0
Baseline, up to Day 120
Secondary outcome [11] 0 0
Change From Baseline to Endpoint in Estradiol
Timepoint [11] 0 0
Baseline, up to Day 120
Secondary outcome [12] 0 0
Change From Baseline to Endpoint in Haemoglobin
Timepoint [12] 0 0
Baseline, up to Day 120
Secondary outcome [13] 0 0
Change From Baseline to Endpoint in Haematocrit - Haematocrit: percentage of total blood volume made up of blood cells
Timepoint [13] 0 0
Baseline, up to Day 120
Secondary outcome [14] 0 0
Change From Baseline to Endpoint in Draize Score - Draize score is a measurement of skin irritability of the application site based on erythema/eschar 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.
Timepoint [14] 0 0
Baseline, Day 120

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
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. - Sydney
Recruitment hospital [2] 0 0
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. - Adelaide
Recruitment hospital [3] 0 0
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. - Melbourne
Recruitment hospital [4] 0 0
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. - Perth
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
France
State/province [12] 0 0
Lyon
Country [13] 0 0
France
State/province [13] 0 0
Nice
Country [14] 0 0
France
State/province [14] 0 0
Nimes
Country [15] 0 0
Germany
State/province [15] 0 0
Bonn
Country [16] 0 0
Germany
State/province [16] 0 0
Freiburg
Country [17] 0 0
Germany
State/province [17] 0 0
Halle
Country [18] 0 0
Sweden
State/province [18] 0 0
Malmo
Country [19] 0 0
Sweden
State/province [19] 0 0
Stockholm
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Barnsley
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Newcastle Upon Tyne
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
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 this study will evaluate the efficacy via pharmacokinetics of various doses of
this product. The study will also assess safety of the product.
Trial website
https://clinicaltrials.gov/show/NCT00702650
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications