Trial Outcomes & Findings for A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations (NCT NCT00857454)
NCT ID: NCT00857454
Last Updated: 2011-01-05
Results Overview
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.
COMPLETED
PHASE3
71 participants
Day 1, Day 190
2011-01-05
Participant Flow
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.
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).
Participant milestones
| Measure |
Testosterone MD-lotion
30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
|
|---|---|
|
Overall Study
STARTED
|
71
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Testosterone MD-lotion
30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Total Testosterone >1050 ng/dL
|
1
|
|
Overall Study
Total Testosterone <300 ng/dL
|
8
|
|
Overall Study
MTE09 enrollment criteria not met
|
6
|
Baseline Characteristics
A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations
Baseline characteristics by cohort
| Measure |
Testosterone MD-lotion
n=71 Participants
30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
|
|---|---|
|
Age Continuous
|
52.3 years
STANDARD_DEVIATION 12.13 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
54 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=99 Participants
|
|
Body Mass Index (BMI)
|
29.78 kilograms per square metter (kg/m^2)
STANDARD_DEVIATION 3.61 • n=99 Participants
|
|
Baseline Total Testosterone Level
|
217.93 nanograms per deciliter (ng/dL)
STANDARD_DEVIATION 84.70 • n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 190Population: Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at MTE09 endpoint (Day 190).
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.
Outcome measures
| Measure |
Testosterone MD-lotion
n=68 Participants
30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
|
|---|---|
|
Change From Baseline MTE08 to MTE09 Endpoint in Draize Score
|
0.0 units on a scale
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Day 1, up to Day 190Population: 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).
Outcome measures
| Measure |
Testosterone MD-lotion
n=66 Participants
30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
|
|---|---|
|
Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin
|
1.43 uIU/mL
Standard Deviation 11.23
|
SECONDARY outcome
Timeframe: Day 1, up to Day 190Population: 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).
Outcome measures
| Measure |
Testosterone MD-lotion
n=65 Participants
30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
|
|---|---|
|
Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose
|
12.25 milligrams per deciliter (mg/dL)
Standard Deviation 35.56
|
SECONDARY outcome
Timeframe: Day 1, up to Day 190Population: 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).
Outcome measures
| Measure |
Testosterone MD-lotion
n=67 Participants
30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
|
|---|---|
|
Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA)
|
0.10 nanograms per milliliter (ng/mL)
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Day 1, up to Day 190Population: 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).
Outcome measures
| Measure |
Testosterone MD-lotion
n=58 Participants
30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
|
|---|---|
|
Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
LH (N=50)
|
-1.39 mIU/mL
Standard Deviation 3.28
|
|
Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
FSH (N=58)
|
-1.82 mIU/mL
Standard Deviation 3.87
|
SECONDARY outcome
Timeframe: Day 1, up to Day 190Population: 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).
Outcome measures
| Measure |
Testosterone MD-lotion
n=32 Participants
30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
|
|---|---|
|
Change From Baseline MTE08 to MTE09 Follow-up in Estradiol
|
2.76 picograms per milliliter (pg/mL)
Standard Deviation 18.97
|
SECONDARY outcome
Timeframe: Day 1, up to Day 190Population: 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).
Outcome measures
| Measure |
Testosterone MD-lotion
n=67 Participants
30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
|
|---|---|
|
Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin
|
0.54 grams per deciliter (g/dL)
Standard Deviation 1.160
|
SECONDARY outcome
Timeframe: Day 1, up to Day 190Population: 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).
Outcome measures
| Measure |
Testosterone MD-lotion
n=66 Participants
30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
|
|---|---|
|
Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit
|
0.03 percentage of red blood cells in sample
Standard Deviation 0.04
|
Adverse Events
Testosterone MD-lotion
Serious adverse events
| Measure |
Testosterone MD-lotion
n=71 participants at risk
30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
|
|---|---|
|
Infections and infestations
Hepatitis c
|
1.4%
1/71 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.4%
1/71 • Number of events 1
|
Other adverse events
| Measure |
Testosterone MD-lotion
n=71 participants at risk
30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
|
|---|---|
|
Cardiac disorders
Cardiac flutter
|
1.4%
1/71 • Number of events 1
|
|
Gastrointestinal disorders
Umbilical hernia
|
1.4%
1/71 • Number of events 1
|
|
General disorders
Application site erythema
|
2.8%
2/71 • Number of events 2
|
|
General disorders
Application site irritation
|
1.4%
1/71 • Number of events 1
|
|
General disorders
Application site oedema
|
1.4%
1/71 • Number of events 1
|
|
General disorders
Asthenia
|
1.4%
1/71 • Number of events 1
|
|
General disorders
Peripheral coldness
|
1.4%
1/71 • Number of events 1
|
|
Infections and infestations
Ear infection
|
1.4%
1/71 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
1.4%
1/71 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/71 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
1/71 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
1.4%
1/71 • Number of events 1
|
|
Investigations
Blood glucose increased
|
1.4%
1/71 • Number of events 1
|
|
Investigations
Blood insulin increased
|
1.4%
1/71 • Number of events 1
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.4%
1/71 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.4%
1/71 • Number of events 1
|
|
Investigations
Haematocrit decreased
|
1.4%
1/71 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
1.4%
1/71 • Number of events 1
|
|
Investigations
Low density lipoprotein increased
|
1.4%
1/71 • Number of events 1
|
|
Investigations
Prostatic specific antigen increased
|
1.4%
1/71 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
1/71 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
2/71 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.4%
1/71 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
1/71 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.4%
1/71 • Number of events 1
|
|
Nervous system disorders
Nerve compression
|
1.4%
1/71 • Number of events 1
|
|
Psychiatric disorders
Libido decreased
|
1.4%
1/71 • Number of events 1
|
|
Reproductive system and breast disorders
Prostatitis
|
1.4%
1/71 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/71 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.4%
1/71 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.8%
2/71 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.4%
1/71 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
1.4%
1/71 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/71 • Number of events 1
|
|
Vascular disorders
Hypertension
|
1.4%
1/71 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60