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| ID | Type | Description | Link |
|---|---|---|---|
| MTE09 | Other Identifier | Acrux | |
| I5E-MC-TSAI | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone MD-lotion | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone MD-Lotion | Drug | 30 mg to 120 mg administered topically once daily for 60 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline MTE08 to MTE09 Endpoint in Draize Score | Draize score is a measurement of skin irritability of the application site based on erythema/escar 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. | Day 1, Day 190 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin | Day 1, up to Day 190 | |
| Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose | Day 1, up to Day 190 | |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | 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. | Birmingham | Alabama |
Participants received 3.0 mL (60 mg) of 2% Testosterone MD-Lotion for 60 days, and may have had their dose adjusted upwards or downwards (Subjects in MTE09 were continued on the dose that they were taking at the conclusion of study MTE08. A total of 2 patients received 30 mg; 49 remained on 60 mg, 12 received 90 mg; and 8 received 120 mg).
This was an open-label extension to the MTE08 trial. Only participants in the MTE08 trial who consented and met eligibility criteria could be enrolled in MTE09.
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| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone MD-lotion | 30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA) |
| Day 1, up to Day 190 |
| Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) | Day 1, up to Day 190 |
| Change From Baseline MTE08 to MTE09 Follow-up in Estradiol | Day 1, up to Day 190 |
| Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin | Day 1, up to Day 190 |
| Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit | Day 1, up to Day 190 |
| 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. | 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. | San Antonio | Texas | United States |
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| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone MD-lotion | 30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms per square metter (kg/m^2) |
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| Baseline Total Testosterone Level | Mean | Standard Deviation | nanograms per deciliter (ng/dL) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline MTE08 to MTE09 Endpoint in Draize Score | Draize score is a measurement of skin irritability of the application site based on erythema/escar 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. | Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at MTE09 endpoint (Day 190). | Posted | Mean | Standard Deviation | units on a scale | Day 1, Day 190 |
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| Secondary | Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin | Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190). | Posted | Mean | Standard Deviation | uIU/mL | Day 1, up to Day 190 |
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| Secondary | Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose | Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190). | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | Day 1, up to Day 190 |
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| Secondary | Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA) | Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190). | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Day 1, up to Day 190 |
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| Secondary | Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) | Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190). | Posted | Mean | Standard Deviation | mIU/mL | Day 1, up to Day 190 |
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| Secondary | Change From Baseline MTE08 to MTE09 Follow-up in Estradiol | Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190). | Posted | Mean | Standard Deviation | picograms per milliliter (pg/mL) | Day 1, up to Day 190 |
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| Secondary | Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin | Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190). | Posted | Mean | Standard Deviation | grams per deciliter (g/dL) | Day 1, up to Day 190 |
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| Secondary | Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit | Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190). | Posted | Mean | Standard Deviation | percentage of red blood cells in sample | Day 1, up to Day 190 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Testosterone MD-lotion | 30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days | 2 | 71 | 22 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis c | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac flutter | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Application site irritation | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Application site oedema | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Peripheral coldness | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Blood insulin increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Haematocrit decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Low density lipoprotein increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Prostatic specific antigen increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Nerve compression | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Libido decreased | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
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| Prostatitis | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D043343 | Testosterone Propionate |
| ID | Term |
|---|---|
| D013739 | Testosterone |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Other |
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| Title | Denominators | Categories | ||||
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| LH (N=50) |
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| FSH (N=58) |
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