Trial Outcomes & Findings for Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men (NCT NCT02432261)
NCT ID: NCT02432261
Last Updated: 2025-02-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-02-13
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
15
|
|
Overall Study
COMPLETED
|
28
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men
Baseline characteristics by cohort
| Measure |
Group 1
n=29 Participants
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
|
Group 2
n=15 Participants
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
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33.7 years
STANDARD_DEVIATION 9.32 • n=5 Participants
|
30.7 years
STANDARD_DEVIATION 7.29 • n=7 Participants
|
32.7 years
STANDARD_DEVIATION 8.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
15 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksTo 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.
Outcome measures
| Measure |
Group 1
n=24 Participants
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
|
Group 2
n=11 Participants
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
|
|---|---|---|
|
Gonadotropin Suppression
|
16 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Group 1
n=24 Participants
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
|
Group 2
n=11 Participants
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
|
|---|---|---|
|
Gonadotropin and Follicle-stimulating Hormone Suppression
|
12 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Group 1
n=24 Participants
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
|
Group 2
n=11 Participants
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
|
|---|---|---|
|
Change in LH and FSH Concentrations
LH
|
-94.55 IU/L
Standard Deviation 26.656
|
-31 IU/L
Standard Deviation 37.638
|
|
Change in LH and FSH Concentrations
FSH
|
-90.25 IU/L
Standard Deviation 24.349
|
-23.1 IU/L
Standard Deviation 33.577
|
SECONDARY outcome
Timeframe: 4 weeksA 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.
Outcome measures
| Measure |
Group 1
n=28 Participants
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
|
Group 2
n=13 Participants
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
|
|---|---|---|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
9 Participants
|
|
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
|
2 Participants
|
|
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
|
2 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The difference in numbers means there was missing data
Outcome measures
| Measure |
Group 1
n=29 Participants
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
|
Group 2
n=15 Participants
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
|
|---|---|---|
|
T Serum Concentrations
Testosterone Day 7
|
502.9 ng/dL
Standard Deviation 409.20
|
674.9 ng/dL
Standard Deviation 283.97
|
|
T Serum Concentrations
Testosterone Day 28: 0 minutes pre-dose
|
602.1 ng/dL
Standard Deviation 476.57
|
828.1 ng/dL
Standard Deviation 567.58
|
|
T Serum Concentrations
Testosterone Day 56 (recovery)
|
594.47 ng/dL
Standard Deviation 217.718
|
595.81 ng/dL
Standard Deviation 205.938
|
SECONDARY outcome
Timeframe: 4 weeksGeneral composite safety as measured various times during the study by CBC-Hemoglobin
Outcome measures
| Measure |
Group 1
n=28 Participants
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
|
Group 2
n=12 Participants
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
|
|---|---|---|
|
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
|
-0.18 g/dl
Standard Deviation 0.634
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Group 1
n=27 Participants
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
|
Group 2
n=12 Participants
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
|
|---|---|---|
|
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
|
-0.17 score on a scale
Standard Deviation 0.676
|
|
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
|
-0.1 score on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 4 weeksChange from baseline to final treatment evaluation-Total Cholesterol, Triglycerides, HDL
Outcome measures
| Measure |
Group 1
n=27 Participants
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
|
Group 2
n=12 Participants
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
|
|---|---|---|
|
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
|
-1.4 mg/dL
Standard Deviation 19.10
|
|
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
|
-15.8 mg/dL
Standard Deviation 26.14
|
|
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
|
-1.8 mg/dL
Standard Deviation 5.65
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The difference in numbers means there was missing data.
Change from baseline to final treatment evaluation
Outcome measures
| Measure |
Group 1
n=28 Participants
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
|
Group 2
n=14 Participants
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
|
|---|---|---|
|
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
|
0.1 mmHg
Standard Deviation 6.20
|
|
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
|
-2.2 mmHg
Standard Deviation 8.08
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The difference in numbers means there was missing data.
Change from baseline to final treatment evaluation
Outcome measures
| Measure |
Group 1
n=28 Participants
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
|
Group 2
n=13 Participants
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
|
|---|---|---|
|
Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes
Skin: Improved
|
0 participants
|
0 participants
|
|
Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes
Skin: No Change
|
27 participants
|
12 participants
|
|
Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes
Skin: Worsened
|
1 participants
|
1 participants
|
|
Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes
Heart: No Change
|
28 participants
|
13 participants
|
|
Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes
Heart: Worsened
|
0 participants
|
0 participants
|
|
Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes
Heart: Improved
|
0 participants
|
0 participants
|
|
Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes
Digital Rectal Exam: Improved
|
0 participants
|
0 participants
|
|
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
|
10 participants
|
|
Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes
Digital Rectal Exam: Worsened
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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).
Outcome measures
| Measure |
Group 1
n=27 Participants
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
|
Group 2
n=12 Participants
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
|
|---|---|---|
|
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
|
-0.1 units on a scale
Standard Deviation 1.14
|
|
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
|
-0.24 units on a scale
Standard Deviation 0.839
|
SECONDARY outcome
Timeframe: 4 weeksPHQ-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).
Outcome measures
| Measure |
Group 1
n=28 Participants
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
|
Group 2
n=13 Participants
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
|
|---|---|---|
|
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
|
0.7 score on a scale
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The difference in numbers means there was missing data
Outcome measures
| Measure |
Group 1
n=29 Participants
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
|
Group 2
n=15 Participants
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
|
|---|---|---|
|
NES Serum Concentrations
Nesterone Day 7
|
679.73 pmol/L
Standard Deviation 716.884
|
9.26 pmol/L
Standard Deviation 34.673
|
|
NES Serum Concentrations
Nesterone Day 28: 0 minutes pre-dose
|
820.60 pmol/L
Standard Deviation 706.619
|
20.70 pmol/L
Standard Deviation 49.697
|
|
NES Serum Concentrations
Nesterone Day 56 (recovery)
|
13.03 pmol/L
Standard Deviation 33.335
|
0 pmol/L
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 4 weeksGeneral composite safety as measured various times during the study by CBC - WBC
Outcome measures
| Measure |
Group 1
n=28 Participants
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
|
Group 2
n=12 Participants
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
|
|---|---|---|
|
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
|
-0.548 WBCs per microliter
Standard Deviation 1.0023
|
SECONDARY outcome
Timeframe: 4 weeksGeneral composite safety as measured various times during the study by CBC-Hematocrit
Outcome measures
| Measure |
Group 1
n=28 Participants
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
|
Group 2
n=12 Participants
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
|
|---|---|---|
|
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 2.650
|
-0.58 percentage of blood
Standard Deviation 1.527
|
SECONDARY outcome
Timeframe: 4 weeksChange from baseline to final treatment evaluation-ALT, AST
Outcome measures
| Measure |
Group 1
n=27 Participants
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
|
Group 2
n=12 Participants
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
|
|---|---|---|
|
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
|
1.6 IU/L
Standard Deviation 15.90
|
|
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
|
0.1 IU/L
Standard Deviation 7.80
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The difference in numbers means there was missing data.
Change from baseline to final treatment evaluation
Outcome measures
| Measure |
Group 1
n=28 Participants
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
|
Group 2
n=12 Participants
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
|
|---|---|---|
|
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
|
1.2 lbs
Standard Deviation 3.6888
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=29 participants at risk
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
|
Group 2
n=15 participants at risk
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
|
|---|---|---|
|
General disorders
DIARRHEA
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
VOMITING
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
General disorders
APPLICATION SITE RASH
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Immune system disorders
HYPERSENSITIVITY
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
LOCALIZED INFECTION
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Periorbital contusion
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
SUNBURN
|
3.4%
1/29 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Investigations
Eosinophil count increased
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
PAIN IN EXTREMITY
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
CONVULSION
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
HEADACE
|
3.4%
1/29 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
SYNCOPE
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Psychiatric disorders
LIBIDO DECREASED
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place