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This is an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations < 297 ng/dL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Testosterone Dose (Inner Thigh) | Experimental | Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the inner thigh followed by a seven day washout period. |
|
| Single Testosterone Dose (Abdomen) | Experimental | Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the abdomen followed by a seven day washout period. |
|
| Single Testosterone Dose (shoulder/upper arm) | Experimental | Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the shoulder/upper arm. |
|
| Testosterone 1.25 | Experimental | Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke) applied once daily for 10 consecutive days to the shoulder/upper arm. |
|
| Testosterone 2.50 | Experimental | Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes) applied once daily for 10 consecutive days to the shoulder/upper arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone gel (FE 99903) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL. | Responder rate was calculated for the subjects who received 10 days of treatment with three doses of testosterone gel; 1.25 mL, 2.50 mL, and 3.75 mL, respectively. The data were presented using descriptive statistics for this outcome. | From Baseline to Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter : Maximum Concentration Observed (Cmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AccuMed Research Associates | Garden City | New York | United States |
Apart from having history of hypogonadism, the study subjects were required to present with one or more symptoms of low testosterone (i.e. fatigue, decreased muscle mass, reduced libido, reduced sexual functioning of a non-mechanical nature). The study subjects needed to be in good health despite exhibiting hypogonadism.
The study was conducted at one study site in the US. Out of 42 subjects screened, 20 subjects were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone Topical | For single dose pharmacokinetics (PKs), a single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the inner thigh followed by a 7-day washout period. After this washout period, the second single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the abdomen followed by another 7-day washout period. After this washout period, the third single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the shoulder/upper arm. After the last 24 hour PK sampling from the shoulder/upper arm, three ascending doses of testosterone gel 2%, 1.25, 2.50 and 3.75 mL (one stroke, two strokes and three strokes, respectively), were sequentially applied once daily for 10 consecutive days to the shoulder/upper arm. Steady-state PK evaluations were performed starting on the morning of the last administered dose. There was no washout between each of the 10-day treatments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The data are presented for Intent-to-treat (ITT) population, which comprised of all subjects who received at least one dose of the Investigational Medicinal Product (IMP). In this study, the safety, ITT, full analysis set (FAS) and per protocol (PP) populations were identical.
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| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone Topical | For single dose PKs, a single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the inner thigh followed by a 7-day washout period. After this washout period, the second single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the abdomen followed by another 7-day washout period. After this washout period, the third single application of 2.50 mL (2 strokes) of the testosterone gel 2% was applied to the shoulder/upper arm. After the last 24 hour PK sampling from the shoulder/upper arm, 3 ascending doses of testosterone gel 2%, 1.25, 2.50 and 3.75 mL (1 stroke, 2 strokes and 3 strokes, respectively), were sequentially applied once daily for 10 consecutive days to the shoulder/upper arm. Steady-state PK evaluations were performed starting on the morning of the last administered dose. There was no washout between each of the 10-day treatments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL. | Responder rate was calculated for the subjects who received 10 days of treatment with three doses of testosterone gel; 1.25 mL, 2.50 mL, and 3.75 mL, respectively. The data were presented using descriptive statistics for this outcome. | ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. | Posted | Number | percentage of subjects | From Baseline to Day 43 |
|
Overall Treatment Period (43 days)
The treatment-emergent adverse event (TEAE), defined as any AE occurring after start of IMP administration and within the time of residual drug effect (5 days) (including PK assessment periods), or a pretreatment AE or preexisting medical condition that worsens in intensity after start of IMP, were presented.
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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 1.25 | Subjects received testosterone gel 2% at dose of 1.25 mL (1 stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
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| ID | Term |
|---|---|
| D005058 | Eunuchism |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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|
| Testosterone 3.75 | Experimental | Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes) applied once daily for 10 consecutive days to the shoulder/upper arm. |
|
| Pharmacokinetic Parameter : Time of Maximum Observed Concentration (Tmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh, and Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13 |
| Pharmacokinetic Parameter : Area Under the Plasma Concentration Time Curve From 0 to 24 hr (AUC0-24) Observed for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13 |
| Pharmacokinetic Parameter - Cmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
| Pharmacokinetic Parameter - Tmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
| Pharmacokinetic Parameter : AUC0-24 Observed for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
| Pharmacokinetic Parameter - Cmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
| Pharmacokinetic Parameter - Tmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
| Pharmacokinetic Parameter : AUC0-24 Observed for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
| Pharmacokinetic Parameter - Cmax for Dihydrotestosterone (DHT) With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
| Pharmacokinetic Parameter - Tmax for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
| Pharmacokinetic Parameter : AUC0-24 Observed for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
| Frequency of Adverse Events (AEs) | The data were presented using descriptive statistics for this outcome. | From Baseline to Day 43 |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Kg/m^2 |
|
| Height | Mean | Standard Deviation | Inch |
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| Weight | Mean | Standard Deviation | lbs |
|
| OG001 | Testosterone 2.50 | Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm. |
| OG002 | Testosterone 3.75 | Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm. |
|
|
| Secondary | Pharmacokinetic Parameter : Maximum Concentration Observed (Cmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. | Posted | Mean | Standard Deviation | ng/dL | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13 |
|
|
|
| Secondary | Pharmacokinetic Parameter : Time of Maximum Observed Concentration (Tmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh, and Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. | Posted | Median | Full Range | hour | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13 |
|
|
|
| Secondary | Pharmacokinetic Parameter : Area Under the Plasma Concentration Time Curve From 0 to 24 hr (AUC0-24) Observed for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 hr. | Posted | Mean | Standard Deviation | ng*hour/dL | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13 |
|
|
|
| Secondary | Pharmacokinetic Parameter - Cmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. | Posted | Mean | Standard Deviation | ng/dL | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
|
|
|
| Secondary | Pharmacokinetic Parameter - Tmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. | Posted | Median | Full Range | hour | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
|
|
|
| Secondary | Pharmacokinetic Parameter : AUC0-24 Observed for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 and/or 24 hr. | Posted | Mean | Standard Deviation | ng*hour/dL | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
|
|
|
| Secondary | Pharmacokinetic Parameter - Cmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. | Posted | Mean | Standard Deviation | pg/mL | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
|
|
|
| Secondary | Pharmacokinetic Parameter - Tmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. | Posted | Median | Full Range | hour | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
|
|
|
| Secondary | Pharmacokinetic Parameter : AUC0-24 Observed for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 and/or 24 hr. | Posted | Mean | Standard Deviation | pg*hour/mL | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
|
|
|
| Secondary | Pharmacokinetic Parameter - Cmax for Dihydrotestosterone (DHT) With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. | Posted | Mean | Standard Deviation | ng/dL | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
|
|
|
| Secondary | Pharmacokinetic Parameter - Tmax for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. | Posted | Median | Full Range | hour | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
|
|
|
| Secondary | Pharmacokinetic Parameter : AUC0-24 Observed for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. | The data were presented using descriptive statistics for this outcome. | ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 and/or 24 hr. | Posted | Mean | Standard Deviation | ng*hour/dL | Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 |
|
|
|
| Secondary | Frequency of Adverse Events (AEs) | The data were presented using descriptive statistics for this outcome. | Safety Analysis Set population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. | Posted | Number | number of event | From Baseline to Day 43 |
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Testosterone 2.50 | Subjects received testosterone gel 2% at dose of 2.50 mL (2 strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm. | 0 | 20 | 2 | 20 |
| EG002 | Testosterone 3.75 | Subjects received testosterone gel 2% at dose of 3.75 mL (3 strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm. | 0 | 20 | 2 | 20 |
| Liver function test abnormal | Investigations | MedDRA (10.1) | Systematic Assessment |
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| Prostatic specific antigen increased | Investigations | MedDRA (10.1) | Systematic Assessment |
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| Nipple pain | Reproductive system and breast disorders | MedDRA (10.1) | Systematic Assessment |
|
There is a restriction on joint publications prepared in collaboration between investigator and sponsor as Ferring reserves the right to be involved in this decision. In the event of any disagreement in the content of any publication both investigator's and Ferring´s opinion will be fairly and sufficiently represented in the publication.