A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00702650
• Date of registration: 19/06/2008
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company
• 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
• Date of first enrolment: June 2008
• Target sample size: 155
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00702650
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, France, Germany, Sweden, United Kingdom, United States

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Hypogonadism

Intervention(s)

Drug: Testosterone MD-Lotion

Primary Outcome(s)

Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120 [Time Frame: Day 120]

Secondary Outcome(s)

Change From Baseline to Endpoint in Haemoglobin [Time Frame: Baseline, up to Day 120]

Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL [Time Frame: Day 120]

Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36) [Time Frame: Baseline, Day 120]

Change From Baseline to Endpoint in Estradiol [Time Frame: Baseline, up to Day 120]

Change From Baseline to Endpoint in Draize Score [Time Frame: Baseline, Day 120]

Change From Baseline to Endpoint in Fasting Glucose [Time Frame: Baseline, up to Day 120]

Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL [Time Frame: Day 120]

Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) [Time Frame: Baseline, up to Day 120]

Change From Baseline to Endpoint in Fasting Insulin [Time Frame: Baseline, up to Day 120]

Percentage of Participants With Cmax Between 1800 and 2500 ng/dL [Time Frame: Day 120]

Change From Baseline to Endpoint in Prostate Specific Antigen (PSA) [Time Frame: Baseline, Day 120]

Change From Baseline to Endpoint in Psychosexual Daily Questionnaire [Time Frame: Baseline, Day 120]

Change From Baseline to Endpoint in Haematocrit [Time Frame: Baseline, up to Day 120]

Percentage of Participants With Cmax >2500 ng/dL [Time Frame: Day 120]

Secondary ID(s)

14272

MTE08

I5E-MC-TSAH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/01/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00702650