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

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism

Intervention: Testosterone MD-Lotion (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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.

Clinical Details

Official 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

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL

Percentage of Participants With Cmax Between 1800 and 2500 ng/dL

Percentage of Participants With Cmax >2500 ng/dL

Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL

Change From Baseline to Endpoint in Psychosexual Daily Questionnaire

Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36)

Change From Baseline to Endpoint in Fasting Insulin

Change From Baseline to Endpoint in Fasting Glucose

Change From Baseline to Endpoint in Prostate Specific Antigen (PSA)

Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)

Change From Baseline to Endpoint in Estradiol

Change From Baseline to Endpoint in Haemoglobin

Change From Baseline to Endpoint in Haematocrit

Change From Baseline to Endpoint in Draize Score

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

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., Lyon, France

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., Nice, France

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., Nimes, France

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., Bonn, Germany

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., Freiburg, Germany

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., Halle, Germany

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., Malmo, Sweden

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., Stockholm, Sweden

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., Barnsley, United Kingdom

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., Newcastle Upon Tyne, United Kingdom

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., Swansea, United Kingdom

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

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

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

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

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., Colorado Springs, Colorado, United States

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., New Britain, Connecticut, United States

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., Ocala, Florida, United States

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., Boise, Idaho, United States

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., Shawnee Mission, Kansas, United States

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., Shreveport, Louisiana, United States

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., Omaha, Nebraska, United States

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, New South Wales, Australia

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, South Australia, Australia

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., San Antonio, Texas, United States

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, Victoria, Australia

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, Western Australia, Australia

Additional Information

Starting date: June 2008
Last updated: July 21, 2011

Page last updated: August 23, 2015

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