Healthy
Conditions
Keywords
spermatogenesis, androgen, male contraception
Brief summary
This is a prospective, randomized, double-blinded, two-center trial to evaluate the gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T gel alone, for 28 days.
Detailed description
A total of 45 subjects will be enrolled and randomized in a 2:1 ratio to one of two treatment groups. A description of each group is as follows: * Group 1 (30 subjects): 5.0 mL of the 1.62% combined gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders * Group 2 (15 subjects): 4.4 mL of the 1.62% AndrogelTM (containing 62.7 mg T) applied each day to the arms and shoulders The total duration of treatment will be 28 days followed by a 72 hour sampling period to assess half-life and a recovery period of at least 28 days, at which point the subjects will return to the clinic for an end of study visit.
Interventions
DRUGNestorone® /testosterone gel
Nestorone® /testosterone combined gel
DRUGTestosterone only gel
Testosterone only gel
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Kimberly Myer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening; 2. 18 to 50 years of age; 3. BMI \< 33 calculated as weight in Kg/(height in cm)2; 4. No history of hormonal therapy use in the last six months prior to the first screening visit; 5. Subject will agree to use a recognized effective method of contraception with his partner (i.e. at a minimum, condom for the male partner and an effective contraception for the female partner) during the course of the study treatment and recovery phase; 6. In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form; 7. Does not meet any of the
Exclusion criteria
. 8. Sperm concentration ≥ 15 million sperm per milliliter ejaculate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gonadotropin Suppression | 4 weeks | To quantify the gonadotropin suppressive activity of 4 weeks daily therapy of a combination transdermal gel containing 8.3 mg Nestorone® (NES) gel and 62.5 mg (1.62%) testosterone (T) gel, and of T gel (1.62%) alone. Specifically, the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone \[LH\] and follicle-stimulating hormone \[FSH\]) to ≤ 1 IU/L in each group, will be quantified. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gonadotropin and Follicle-stimulating Hormone Suppression | 4 weeks | • To quantify the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone \[LH\] and follicle-stimulating hormone \[FSH\]) to the detection limit of the assay in each group. |
| Change in LH and FSH Concentrations | 4 weeks | • To quantify the median percent change from baseline to week 4 and interquartile range for serum gonadotropins (LH and FSH) concentrations for each treatment group. |
| Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations. | 4 weeks | A simple acceptability questionnaire used previously in male CCTN studies was administered at treatment Day 28 (28, 29) for subjects to answer questions about the acceptability of gel as a product and as a method for contraception over the preceding 4 weeks. |
| T Serum Concentrations | 8 weeks | — |
| Secondary Outcome # 6 Part 1a: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hemoglobin) | 4 weeks | General composite safety as measured various times during the study by CBC-Hemoglobin |
| Assessing Sexual Function by Compare Gonadotropin Suppressive Activity of T and NES Against T Alone Through the Psychosexual Daily Questionnaire. | 4 weeks | Sexual activity was rated on a scale from 0 (not at all) to 7 (very high enjoyment/pleasure). Erections were rated on a scale of 0 (not satisfactory) to 7 (very satisfactory). Results are change from baseline to final treatment evaluation. |
| Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | 4 weeks | Change from baseline to final treatment evaluation-Total Cholesterol, Triglycerides, HDL |
| Secondary Outcome # 6 Part 5: A Composite Safety of the Combined Gel Determined by Outcomes of Psychosexual Questionnaires | 4 weeks | Change from baseline to final treatment evaluation. Sexual motivation was rated on a scale of 0 (none) to 7 (very high). Erections were rated on a scale of 0 (not satisfactory) to 7 (very satisfactory). |
| Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | 4 weeks | Change from baseline to final treatment evaluation |
| Secondary Outcome # 6 Part 3: A Composite Safety of the Combined Gel Determined by Outcomes of Patient Health Questionnaires | 4 weeks | PHQ-9 Total Score: Change from baseline to final treatment evaluation. The Patient Health Questionnaire (PHQ)-9 is a self-administered instrument for screening, monitoring and diagnosis of depression. This questionnaire can be used repeatedly to monitor improvement or worsening of symptoms. Scale range is from 0 (not at all) to 3 (nearly every day). |
| NES Serum Concentrations | 8 weeks | — |
| Secondary Outcome # 6 Part 1b: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (WBC) | 4 weeks | General composite safety as measured various times during the study by CBC - WBC |
| Secondary Outcome # 6 Part 1c: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hematocrit) | 4 weeks | General composite safety as measured various times during the study by CBC-Hematocrit |
| Secondary Outcome # 6 Part 2b: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | 4 weeks | Change from baseline to final treatment evaluation-ALT, AST |
| Secondary Outcome # 6 Part 3b: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Weight) | 4 weeks | Change from baseline to final treatment evaluation |
| Secondary Outcome # 6 Part 3a: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Blood Pressure) | 4 weeks | Change from baseline to final treatment evaluation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders
Nestorone® /testosterone gel: Nestorone® /testosterone combined gel | 29 |
| Group 2 4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders
Testosterone only gel: Testosterone only gel | 15 |
| Total | 44 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 15 Participants | 44 Participants |
| Age, Continuous | 33.7 years STANDARD_DEVIATION 9.32 | 30.7 years STANDARD_DEVIATION 7.29 | 32.7 years STANDARD_DEVIATION 8.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 2 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 12 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 16 Participants | 6 Participants | 22 Participants |
| Region of Enrollment United States | 29 participants | 15 participants | 44 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 29 Participants | 15 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 15 |
| other Total, other adverse events | 10 / 29 | 5 / 15 |
| serious Total, serious adverse events | 0 / 29 | 0 / 15 |
Outcome results
Primary
Gonadotropin Suppression
To quantify the gonadotropin suppressive activity of 4 weeks daily therapy of a combination transdermal gel containing 8.3 mg Nestorone® (NES) gel and 62.5 mg (1.62%) testosterone (T) gel, and of T gel (1.62%) alone. Specifically, the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone \[LH\] and follicle-stimulating hormone \[FSH\]) to ≤ 1 IU/L in each group, will be quantified.
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Gonadotropin Suppression | 16 Participants |
| Group 2 | Gonadotropin Suppression | 1 Participants |
p-value: 0.003Fisher Exact
Secondary
Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations.
A simple acceptability questionnaire used previously in male CCTN studies was administered at treatment Day 28 (28, 29) for subjects to answer questions about the acceptability of gel as a product and as a method for contraception over the preceding 4 weeks.
Time frame: 4 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations. | Overall satisfaction: disagree | 1 Participants |
| Group 1 | Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations. | Overall satisfaction: agree | 15 Participants |
| Group 1 | Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations. | Overall satisfaction: undecided | 4 Participants |
| Group 1 | Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations. | Overall satisfaction: Strongly agree | 7 Participants |
| Group 1 | Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations. | Overall satisfaction: Strongly disagree | 1 Participants |
| Group 2 | Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations. | Overall satisfaction: Strongly agree | 2 Participants |
| Group 2 | Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations. | Overall satisfaction: Strongly disagree | 0 Participants |
| Group 2 | Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations. | Overall satisfaction: disagree | 0 Participants |
| Group 2 | Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations. | Overall satisfaction: undecided | 2 Participants |
| Group 2 | Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations. | Overall satisfaction: agree | 9 Participants |
Secondary
Assessing Sexual Function by Compare Gonadotropin Suppressive Activity of T and NES Against T Alone Through the Psychosexual Daily Questionnaire.
Sexual activity was rated on a scale from 0 (not at all) to 7 (very high enjoyment/pleasure). Erections were rated on a scale of 0 (not satisfactory) to 7 (very satisfactory). Results are change from baseline to final treatment evaluation.
Time frame: 4 weeks
Population: The difference in numbers means there was missing data in the questionnaire which caused some of the domains to have missing results while some domains could have a score calculated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Assessing Sexual Function by Compare Gonadotropin Suppressive Activity of T and NES Against T Alone Through the Psychosexual Daily Questionnaire. | Sexual Activity | -0.18 score on a scale | Standard Deviation 1.483 |
| Group 1 | Assessing Sexual Function by Compare Gonadotropin Suppressive Activity of T and NES Against T Alone Through the Psychosexual Daily Questionnaire. | Erections | -0.6 score on a scale | Standard Deviation 2.47 |
| Group 2 | Assessing Sexual Function by Compare Gonadotropin Suppressive Activity of T and NES Against T Alone Through the Psychosexual Daily Questionnaire. | Sexual Activity | -0.17 score on a scale | Standard Deviation 0.676 |
| Group 2 | Assessing Sexual Function by Compare Gonadotropin Suppressive Activity of T and NES Against T Alone Through the Psychosexual Daily Questionnaire. | Erections | -0.1 score on a scale | Standard Deviation 1.14 |
Secondary
Change in LH and FSH Concentrations
• To quantify the median percent change from baseline to week 4 and interquartile range for serum gonadotropins (LH and FSH) concentrations for each treatment group.
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Change in LH and FSH Concentrations | LH | -94.55 IU/L | Standard Deviation 26.656 |
| Group 1 | Change in LH and FSH Concentrations | FSH | -90.25 IU/L | Standard Deviation 24.349 |
| Group 2 | Change in LH and FSH Concentrations | LH | -31 IU/L | Standard Deviation 37.638 |
| Group 2 | Change in LH and FSH Concentrations | FSH | -23.1 IU/L | Standard Deviation 33.577 |
Secondary
Gonadotropin and Follicle-stimulating Hormone Suppression
• To quantify the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone \[LH\] and follicle-stimulating hormone \[FSH\]) to the detection limit of the assay in each group.
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Gonadotropin and Follicle-stimulating Hormone Suppression | 12 Participants |
| Group 2 | Gonadotropin and Follicle-stimulating Hormone Suppression | 1 Participants |
Secondary
NES Serum Concentrations
Time frame: 8 weeks
Population: The difference in numbers means there was missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | NES Serum Concentrations | Nesterone Day 7 | 679.73 pmol/L | Standard Deviation 716.884 |
| Group 1 | NES Serum Concentrations | Nesterone Day 28: 0 minutes pre-dose | 820.60 pmol/L | Standard Deviation 706.619 |
| Group 1 | NES Serum Concentrations | Nesterone Day 56 (recovery) | 13.03 pmol/L | Standard Deviation 33.335 |
| Group 2 | NES Serum Concentrations | Nesterone Day 7 | 9.26 pmol/L | Standard Deviation 34.673 |
| Group 2 | NES Serum Concentrations | Nesterone Day 28: 0 minutes pre-dose | 20.70 pmol/L | Standard Deviation 49.697 |
| Group 2 | NES Serum Concentrations | Nesterone Day 56 (recovery) | 0 pmol/L | Standard Deviation 0 |
Secondary
Secondary Outcome # 6 Part 1a: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hemoglobin)
General composite safety as measured various times during the study by CBC-Hemoglobin
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Secondary Outcome # 6 Part 1a: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hemoglobin) | 0.01 g/dl | Standard Deviation 0.924 |
| Group 2 | Secondary Outcome # 6 Part 1a: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hemoglobin) | -0.18 g/dl | Standard Deviation 0.634 |
Secondary
Secondary Outcome # 6 Part 1b: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (WBC)
General composite safety as measured various times during the study by CBC - WBC
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Secondary Outcome # 6 Part 1b: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (WBC) | 0.182 WBCs per microliter | Standard Deviation 0.9772 |
| Group 2 | Secondary Outcome # 6 Part 1b: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (WBC) | -0.548 WBCs per microliter | Standard Deviation 1.0023 |
Secondary
Secondary Outcome # 6 Part 1c: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hematocrit)
General composite safety as measured various times during the study by CBC-Hematocrit
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Secondary Outcome # 6 Part 1c: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hematocrit) | 0.19 percentage of blood | Standard Deviation 2.65 |
| Group 2 | Secondary Outcome # 6 Part 1c: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hematocrit) | -0.58 percentage of blood | Standard Deviation 1.527 |
Secondary
Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry
Change from baseline to final treatment evaluation-Total Cholesterol, Triglycerides, HDL
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | Total Cholesterol | -5.8 mg/dL | Standard Deviation 18.21 |
| Group 1 | Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | Triglycerides | -12.2 mg/dL | Standard Deviation 31.16 |
| Group 1 | Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | HDL | -2.3 mg/dL | Standard Deviation 7.65 |
| Group 2 | Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | Total Cholesterol | -1.4 mg/dL | Standard Deviation 19.1 |
| Group 2 | Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | Triglycerides | -15.8 mg/dL | Standard Deviation 26.14 |
| Group 2 | Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | HDL | -1.8 mg/dL | Standard Deviation 5.65 |
Secondary
Secondary Outcome # 6 Part 2b: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry
Change from baseline to final treatment evaluation-ALT, AST
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Secondary Outcome # 6 Part 2b: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | ALT | -4.4 IU/L | Standard Deviation 7.89 |
| Group 1 | Secondary Outcome # 6 Part 2b: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | AST | -2.0 IU/L | Standard Deviation 9.59 |
| Group 2 | Secondary Outcome # 6 Part 2b: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | ALT | 0.1 IU/L | Standard Deviation 7.8 |
| Group 2 | Secondary Outcome # 6 Part 2b: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | AST | 1.6 IU/L | Standard Deviation 15.9 |
Secondary
Secondary Outcome # 6 Part 3a: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Blood Pressure)
Change from baseline to final treatment evaluation
Time frame: 4 weeks
Population: The difference in numbers means there was missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Secondary Outcome # 6 Part 3a: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Blood Pressure) | Systolic BP | 2.8 mmHg | Standard Deviation 6.91 |
| Group 1 | Secondary Outcome # 6 Part 3a: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Blood Pressure) | Diastolic BP | 1.8 mmHg | Standard Deviation 6.57 |
| Group 2 | Secondary Outcome # 6 Part 3a: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Blood Pressure) | Systolic BP | -2.2 mmHg | Standard Deviation 8.08 |
| Group 2 | Secondary Outcome # 6 Part 3a: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Blood Pressure) | Diastolic BP | 0.1 mmHg | Standard Deviation 6.2 |
Secondary
Secondary Outcome # 6 Part 3: A Composite Safety of the Combined Gel Determined by Outcomes of Patient Health Questionnaires
PHQ-9 Total Score: Change from baseline to final treatment evaluation. The Patient Health Questionnaire (PHQ)-9 is a self-administered instrument for screening, monitoring and diagnosis of depression. This questionnaire can be used repeatedly to monitor improvement or worsening of symptoms. Scale range is from 0 (not at all) to 3 (nearly every day).
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Secondary Outcome # 6 Part 3: A Composite Safety of the Combined Gel Determined by Outcomes of Patient Health Questionnaires | 0.6 score on a scale | Standard Deviation 1.73 |
| Group 2 | Secondary Outcome # 6 Part 3: A Composite Safety of the Combined Gel Determined by Outcomes of Patient Health Questionnaires | 0.7 score on a scale | Standard Deviation 1.44 |
Secondary
Secondary Outcome # 6 Part 3b: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Weight)
Change from baseline to final treatment evaluation
Time frame: 4 weeks
Population: The difference in numbers means there was missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Secondary Outcome # 6 Part 3b: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Weight) | 0.045 lbs | Standard Deviation 3.8638 |
| Group 2 | Secondary Outcome # 6 Part 3b: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Weight) | 1.2 lbs | Standard Deviation 3.6888 |
Secondary
Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes
Change from baseline to final treatment evaluation
Time frame: 4 weeks
Population: The difference in numbers means there was missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Skin: Worsened | 1 participants |
| Group 1 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Heart: No Change | 28 participants |
| Group 1 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Digital Rectal Exam: Worsened | 0 participants |
| Group 1 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Heart: Worsened | 0 participants |
| Group 1 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Heart: Improved | 0 participants |
| Group 1 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Digital Rectal Exam: Improved | 0 participants |
| Group 1 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Skin: Improved | 0 participants |
| Group 1 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Digital Rectal Exam: No Change | 16 participants |
| Group 1 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Skin: No Change | 27 participants |
| Group 2 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Digital Rectal Exam: No Change | 10 participants |
| Group 2 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Skin: No Change | 12 participants |
| Group 2 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Skin: Worsened | 1 participants |
| Group 2 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Heart: Improved | 0 participants |
| Group 2 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Digital Rectal Exam: Worsened | 0 participants |
| Group 2 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Skin: Improved | 0 participants |
| Group 2 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Heart: No Change | 13 participants |
| Group 2 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Heart: Worsened | 0 participants |
| Group 2 | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Digital Rectal Exam: Improved | 0 participants |
Secondary
Secondary Outcome # 6 Part 5: A Composite Safety of the Combined Gel Determined by Outcomes of Psychosexual Questionnaires
Change from baseline to final treatment evaluation. Sexual motivation was rated on a scale of 0 (none) to 7 (very high). Erections were rated on a scale of 0 (not satisfactory) to 7 (very satisfactory).
Time frame: 4 weeks
Population: The difference in numbers means there was missing data in the questionnaire which caused some of the domains to have missing results while some domains could have a score calculated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Secondary Outcome # 6 Part 5: A Composite Safety of the Combined Gel Determined by Outcomes of Psychosexual Questionnaires | Sexual Motivation: Change from baseline to final treatment | 0.01 units on a scale | Standard Deviation 1.765 |
| Group 1 | Secondary Outcome # 6 Part 5: A Composite Safety of the Combined Gel Determined by Outcomes of Psychosexual Questionnaires | Erections: Change from baseline to final treatment | -0.6 units on a scale | Standard Deviation 2.47 |
| Group 2 | Secondary Outcome # 6 Part 5: A Composite Safety of the Combined Gel Determined by Outcomes of Psychosexual Questionnaires | Sexual Motivation: Change from baseline to final treatment | -0.24 units on a scale | Standard Deviation 0.839 |
| Group 2 | Secondary Outcome # 6 Part 5: A Composite Safety of the Combined Gel Determined by Outcomes of Psychosexual Questionnaires | Erections: Change from baseline to final treatment | -0.1 units on a scale | Standard Deviation 1.14 |
Secondary
T Serum Concentrations
Time frame: 8 weeks
Population: The difference in numbers means there was missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | T Serum Concentrations | Testosterone Day 7 | 502.9 ng/dL | Standard Deviation 409.2 |
| Group 1 | T Serum Concentrations | Testosterone Day 28: 0 minutes pre-dose | 602.1 ng/dL | Standard Deviation 476.57 |
| Group 1 | T Serum Concentrations | Testosterone Day 56 (recovery) | 594.47 ng/dL | Standard Deviation 217.718 |
| Group 2 | T Serum Concentrations | Testosterone Day 28: 0 minutes pre-dose | 828.1 ng/dL | Standard Deviation 567.58 |
| Group 2 | T Serum Concentrations | Testosterone Day 7 | 674.9 ng/dL | Standard Deviation 283.97 |
| Group 2 | T Serum Concentrations | Testosterone Day 56 (recovery) | 595.81 ng/dL | Standard Deviation 205.938 |