A Phase 3 interventional study of Testosterone MD-Lotion in Hypogonadism, sponsored by Eli Lilly and Company. Completed at 11 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-05.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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.
345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.
This study's enrollment of 71 is above the median of 56 across 260 interventional studies indexed under Hypogonadism.
Browse Hypogonadism studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Any man in whom testosterone therapy was contraindicated, which included those with:
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).
Drug: Testosterone MD-Lotion
30 mg to 120 mg administered topically once daily for 60 days
Also known as: LY900011, Axiron
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.
Time frame: Day 1, Day 190
Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin
Time frame: Day 1, up to Day 190
Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose
Time frame: Day 1, up to Day 190
Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA)
Time frame: Day 1, up to Day 190
Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
Time frame: Day 1, up to Day 190
Change From Baseline MTE08 to MTE09 Follow-up in Estradiol
Time frame: Day 1, up to Day 190
Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin
Time frame: Day 1, up to Day 190
Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit
Time frame: Day 1, up to Day 190
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.
| Milestone | Testosterone MD-lotion |
|---|---|
| Started | 71 |
| Completed | 51 |
| Not completed | 20 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Adverse event | 2 |
| Withdrew: Total testosterone >1050 ng/dl | 1 |
| Withdrew: Total testosterone <300 ng/dl | 8 |
| Withdrew: Mte09 enrollment criteria not met | 6 |
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.
| units on a scale | Testosterone MD-lotion |
|---|---|
| Change From Baseline MTE08 to MTE09 Endpoint in Draize Score | 0.0 ± 0.12 |
| uIU/mL | Testosterone MD-lotion |
|---|---|
| Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin | 1.43 ± 11.23 |
| milligrams per deciliter (mg/dL) | Testosterone MD-lotion |
|---|---|
| Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose | 12.25 ± 35.56 |
| nanograms per milliliter (ng/mL) | Testosterone MD-lotion |
|---|---|
| Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA) | 0.10 ± 0.54 |
| mIU/mL | Testosterone MD-lotion |
|---|---|
| LH (N=50) | -1.39 ± 3.28 |
| FSH (N=58) | -1.82 ± 3.87 |
| picograms per milliliter (pg/mL) | Testosterone MD-lotion |
|---|---|
| Change From Baseline MTE08 to MTE09 Follow-up in Estradiol | 2.76 ± 18.97 |
| grams per deciliter (g/dL) | Testosterone MD-lotion |
|---|---|
| Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin | 0.54 ± 1.160 |
| percentage of red blood cells in sample | Testosterone MD-lotion |
|---|---|
| Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit | 0.03 ± 0.04 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Testosterone MD-lotion | — | 2/71 (2.8%) | 22/71 (31%) |
| Event | Testosterone MD-lotion |
|---|---|
| Hepatitis cInfections and infestations | 1/71 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/71 |
| Event | Testosterone MD-lotion |
|---|---|
| Application site erythemaGeneral disorders | 2/71 |
| Back painMusculoskeletal and connective tissue disorders | 2/71 |
| Dry skinSkin and subcutaneous tissue disorders | 2/71 |
| Cardiac flutterCardiac disorders | 1/71 |
| Umbilical herniaGastrointestinal disorders | 1/71 |
| Application site irritationGeneral disorders | 1/71 |
| Application site oedemaGeneral disorders | 1/71 |
| AstheniaGeneral disorders | 1/71 |
| Peripheral coldnessGeneral disorders | 1/71 |
| Ear infectionInfections and infestations | 1/71 |
| Age Continuous(years) | Testosterone MD-lotion |
|---|---|
| Mean | 52.3 ± 12.13 |
| Sex: Female, Male(Participants) | Testosterone MD-lotion |
|---|---|
| Female | 0 |
| Male | 71 |
| Race/Ethnicity, Customized(participants) | Testosterone MD-lotion |
|---|---|
| Caucasian | 54 |
| African American | 6 |
| Hispanic | 10 |
| Other | 1 |
| Region of Enrollment(participants) | Testosterone MD-lotion |
|---|---|
| United States | 71 |
| Body Mass Index (BMI)(kilograms per square metter (kg/m^2)) | Testosterone MD-lotion |
|---|---|
| Mean | 29.78 ± 3.61 |
| Baseline Total Testosterone Level(nanograms per deciliter (ng/dL)) | Testosterone MD-lotion |
|---|---|
| Mean | 217.93 ± 84.70 |
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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