Hypogonadal Males
Conditions
Brief summary
This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum testosterone concentrations \<300 ng/dL. The purpose of this study is to evaluate the pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand application
Interventions
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18-75 * History of hypogonadism * In good health based on medical history, physical examination, and clinical laboratory tests * Serum testosterone deficiency * One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or reduced sexual functioning) * Body mass index (BMI) between 18 and 35 kg/m\^2 * All screening lab tests within 20% of the normal range (exceptions are liver function tests) * HIV, Hepatitis B and C negative
Exclusion criteria
* Previous use of FE 999303 * Prostate cancer * Breast carcinoma, patient or partner * Palpable prostatic mass(es) * Serum PSA levels ≥3 ng/dL * Chronic use of any drug of abuse * Lower urinary tract obstruction * Clinically significant anemia or renal dysfunction * Cardiovascular disease * Hyperparathyroidism or uncontrolled diabetes * Generalized skin irritation or significant skin disease * Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, 5-alfa-reductase-inhibitors, ketoconazole, abiraterone) * Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous 12 months of screening) * Use of testosterone products (within 8 weeks of screening for parenteral products, or 6 weeks of screening for other preparations) * Sleep apnea * Untreated depression * Subject with a partner who is pregnant or will not use contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator. | Days 15-21, Days 22-28 & Days 29-35 | Descriptive statistics was used to present the outcome results. |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ) | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
| Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax) | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
| Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax) | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
| Pharmacokinetics of Total Testosterone and DHT Measuring Cavg | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
| Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin) | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
| Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand. | Days 1-7 |
| Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
| Pharmacokinetics of Total Testosterone and DHT Measuring Tmax | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
| Pharmacokinetics of Total Testosterone and DHT Measuring Cmax | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
| Pharmacokinetics of Total Testosterone and DHT Measuring Cmin | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
| Pharmacokinetics of Total Testosterone and DHT Measuring Tmin | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
| Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin) | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
Countries
United States
Participant flow
Recruitment details
The study was conducted at one study site in the US. Out of 78 subjects screened, 20 subjects were enrolled in the study.
Pre-assignment details
Apart from having history of hypogonadism, the study subjects were required to present with one or more symptoms of testosterone deficiency (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.
Participants by arm
| Arm | Count |
|---|---|
| Testosterone Topical Initially study subjects self-applied 2.50 mL (two strokes) of testosterone gel by hand every day for seven days followed by a 7-day washout period. After washout period, study subjects sequentially self-applied ascending doses of testosterone gel with the applicator; 1.25 mL (one stroke), 2.50 mL (two strokes), and 3.75 mL (three strokes), respectively every day for seven days with no washout period in between. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Non-compliance | 1 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Testosterone Topical |
|---|---|
| Age, Continuous | 52.1 Year STANDARD_DEVIATION 8.2 |
| Body Mass Index (BMI) | 29.8 kg/m^2 STANDARD_DEVIATION 3.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 69.2 inch STANDARD_DEVIATION 2.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 20 subjects |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 20 Participants |
| Weight | 203.7 lbs STANDARD_DEVIATION 29.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.
Descriptive statistics was used to present the outcome results.
Time frame: Days 15-21, Days 22-28 & Days 29-35
Population: Full Analysis Set (FAS) population was used for this analysis, which comprised of all subjects who had any available Pharmacokinetic (PK) data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Testosterone 1.25 mL (Applicator) | Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator. | 16.7 percentage of subjects |
| Testosterone 2.50 mL (Applicator) | Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator. | 50.0 percentage of subjects |
| Testosterone 3.75 mL (Applicator) | Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator. | 77.8 percentage of subjects |
Secondary
Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Population: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ) | Testosterone | 5768 ng*hr/dL | Standard Deviation 1228 |
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ) | DHT | 688 ng*hr/dL | Standard Deviation 349 |
| Testosterone 2.50 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ) | Testosterone | 7686 ng*hr/dL | Standard Deviation 2648 |
| Testosterone 2.50 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ) | DHT | 974 ng*hr/dL | Standard Deviation 674 |
| Testosterone 3.75 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ) | Testosterone | 10295 ng*hr/dL | Standard Deviation 3764 |
| Testosterone 3.75 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ) | DHT | 1223 ng*hr/dL | Standard Deviation 666 |
Secondary
Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Population: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ | Testosterone | 7809 ng*hr/dL | Standard Deviation 2609 |
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ | DHT | 1143 ng*hr/dL | Standard Deviation 740 |
Secondary
Pharmacokinetics of Total Testosterone and DHT Measuring Cavg
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Population: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Cavg | Testosterone | 325 ng/dL | Standard Deviation 109 |
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Cavg | DHT | 47.6 ng/dL | Standard Deviation 30.8 |
Secondary
Pharmacokinetics of Total Testosterone and DHT Measuring Cavg
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Population: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Cavg | Testosterone | 240 ng/dL | Standard Deviation 51 |
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Cavg | DHT | 28.7 ng/dL | Standard Deviation 14.5 |
| Testosterone 2.50 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Cavg | Testosterone | 320 ng/dL | Standard Deviation 110 |
| Testosterone 2.50 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Cavg | DHT | 40.6 ng/dL | Standard Deviation 28.2 |
| Testosterone 3.75 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Cavg | Testosterone | 429 ng/dL | Standard Deviation 157 |
| Testosterone 3.75 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Cavg | DHT | 51.0 ng/dL | Standard Deviation 27.7 |
Secondary
Pharmacokinetics of Total Testosterone and DHT Measuring Cmax
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Population: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Cmax | Testosterone | 517 ng/dL | Standard Deviation 381 |
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Cmax | DHT | 69.1 ng/dL | Standard Deviation 58.1 |
Secondary
Pharmacokinetics of Total Testosterone and DHT Measuring Cmin
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Population: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Cmin | Testosterone | 234 ng/dL | Standard Deviation 62 |
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Cmin | DHT | 35.4 ng/dL | Standard Deviation 19 |
Secondary
Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Population: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax) | Testosterone | 396 ng/dL | Standard Deviation 137 |
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax) | DHT | 37.6 ng/dL | Standard Deviation 20.3 |
| Testosterone 2.50 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax) | Testosterone | 641 ng/dL | Standard Deviation 319 |
| Testosterone 2.50 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax) | DHT | 57.7 ng/dL | Standard Deviation 39 |
| Testosterone 3.75 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax) | Testosterone | 1024 ng/dL | Standard Deviation 700 |
| Testosterone 3.75 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax) | DHT | 78.9 ng/dL | Standard Deviation 58.3 |
Secondary
Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Population: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin) | Testosterone | 173 ng/dL | Standard Deviation 47 |
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin) | DHT | 21.1 ng/dL | Standard Deviation 9 |
| Testosterone 2.50 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin) | Testosterone | 213 ng/dL | Standard Deviation 69 |
| Testosterone 2.50 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin) | DHT | 29.9 ng/dL | Standard Deviation 21.9 |
| Testosterone 3.75 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin) | Testosterone | 250 ng/dL | Standard Deviation 116 |
| Testosterone 3.75 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin) | DHT | 37.3 ng/dL | Standard Deviation 22.9 |
Secondary
Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Population: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax) | Testosterone | 3.77 hr |
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax) | DHT | 3.75 hr |
| Testosterone 2.50 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax) | Testosterone | 3.77 hr |
| Testosterone 2.50 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax) | DHT | 3.78 hr |
| Testosterone 3.75 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax) | Testosterone | 3.77 hr |
| Testosterone 3.75 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax) | DHT | 3.86 hr |
Secondary
Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin)
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Population: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin) | Testosterone | 7.78 hr |
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin) | DHT | 9.83 hr |
| Testosterone 2.50 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin) | Testosterone | 10.81 hr |
| Testosterone 2.50 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin) | DHT | 11.0 hr |
| Testosterone 3.75 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin) | Testosterone | 4.76 hr |
| Testosterone 3.75 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin) | DHT | 9.79 hr |
Secondary
Pharmacokinetics of Total Testosterone and DHT Measuring Tmax
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Population: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Tmax | Testosterone | 1.86 hr |
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Tmax | DHT | 1.86 hr |
Secondary
Pharmacokinetics of Total Testosterone and DHT Measuring Tmin
Time frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Population: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Tmin | Testosterone | 8.84 hr |
| Testosterone 1.25 mL (Applicator) | Pharmacokinetics of Total Testosterone and DHT Measuring Tmin | DHT | 11.8 hr |
Secondary
Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand.
Time frame: Days 1-7
Population: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Testosterone 1.25 mL (Applicator) | Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand. | 50 percentage of subjects |