Trial Outcomes & Findings for Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males (NCT NCT02994602)

Last Updated: 2026-02-09

Results Overview

Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cavg after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

26 participants

Primary outcome timeframe

Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

Results posted on

2026-02-09

Participant Flow

13 partners were enrolled (13 females and 13 males); Planned enrollment was 24 but study enrolled 26 participants.

Participant milestones

Participant milestones
Measure	Nestorone (NES) + Testosterone (T) Combined Gel A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
Overall Study STARTED	26
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Characteristics were measured for the male subjects and their female partners, and provided separately.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nestorone (NES) + Testosterone (T) Combined Gel n=26 Participants A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
Age, Categorical Male Subjects · <=18 years	0 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Age, Categorical Male Subjects · Between 18 and 65 years	13 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Age, Categorical Male Subjects · >=65 years	0 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Age, Categorical Female Subjects · <=18 years	0 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Age, Categorical Female Subjects · Between 18 and 65 years	13 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Age, Categorical Female Subjects · >=65 years	0 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Age, Continuous Male Subjects	29.4 years STANDARD_DEVIATION 7.82 • n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Age, Continuous Female Subjects	25.9 years STANDARD_DEVIATION 4.35 • n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Sex: Female, Male Female	13 Participants n=26 Participants
Sex: Female, Male Male	13 Participants n=26 Participants
Ethnicity (NIH/OMB) Male Subjects · Hispanic or Latino	5 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Ethnicity (NIH/OMB) Male Subjects · Not Hispanic or Latino	8 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Ethnicity (NIH/OMB) Male Subjects · Unknown or Not Reported	0 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Ethnicity (NIH/OMB) Female Subjects · Hispanic or Latino	6 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Ethnicity (NIH/OMB) Female Subjects · Not Hispanic or Latino	7 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Ethnicity (NIH/OMB) Female Subjects · Unknown or Not Reported	0 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Race (NIH/OMB) Male Subjects · American Indian or Alaska Native	1 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Race (NIH/OMB) Male Subjects · Asian	1 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Race (NIH/OMB) Male Subjects · Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Race (NIH/OMB) Male Subjects · Black or African American	3 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Race (NIH/OMB) Male Subjects · White	6 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Race (NIH/OMB) Male Subjects · More than one race	0 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Race (NIH/OMB) Male Subjects · Unknown or Not Reported	2 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Race (NIH/OMB) Female Subjects · American Indian or Alaska Native	0 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Race (NIH/OMB) Female Subjects · Asian	1 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Race (NIH/OMB) Female Subjects · Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Race (NIH/OMB) Female Subjects · Black or African American	1 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Race (NIH/OMB) Female Subjects · White	7 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Race (NIH/OMB) Female Subjects · More than one race	3 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Race (NIH/OMB) Female Subjects · Unknown or Not Reported	1 Participants n=13 Participants • Characteristics were measured for the male subjects and their female partners, and provided separately.
Region of Enrollment United States	26 participants n=26 Participants • All subjects were enrolled in the United States.

PRIMARY outcome

Timeframe: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

Population: includes female participants that completed the skin contact types

Outcome measures

Outcome measures
Measure	Nestorone (NES) + Testosterone (T) Combined Gel n=13 Participants A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
Changes From Baseline (Cavg) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel Baseline	22.84 ng/dL Standard Deviation 8.98
Changes From Baseline (Cavg) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel With T-shirt Clothing Barrier	27.12 ng/dL Standard Deviation 9.53
Changes From Baseline (Cavg) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel Shower and Dried	29.12 ng/dL Standard Deviation 11.19
Changes From Baseline (Cavg) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel No Intervention	62.06 ng/dL Standard Deviation 35.68

PRIMARY outcome

Timeframe: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

Population: includes female participants that completed the skin contact types

Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmin after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.

Outcome measures

Outcome measures
Measure	Nestorone (NES) + Testosterone (T) Combined Gel n=13 Participants A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
Changes From Baseline (Cmin) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel Baseline	20.63 ng/dL Standard Deviation 9.13
Changes From Baseline (Cmin) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel With T-shirt Clothing Barrier	21.26 ng/dL Standard Deviation 9.04
Changes From Baseline (Cmin) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel Shower and Dried	23.27 ng/dL Standard Deviation 10.88
Changes From Baseline (Cmin) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel No Intervention	22.94 ng/dL Standard Deviation 10.07

PRIMARY outcome

Timeframe: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

Population: includes female participants that completed the skin contact types

Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmax after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.

Outcome measures

Outcome measures
Measure	Nestorone (NES) + Testosterone (T) Combined Gel n=13 Participants A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
Changes From Baseline (Cmax) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel Baseline	31.8 ng/dL Standard Deviation 12.0
Changes From Baseline (Cmax) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel With T-shirt Clothing Barrier	39.4 ng/dL Standard Deviation 12.9
Changes From Baseline (Cmax) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel Shower and Dried	48.1 ng/dL Standard Deviation 23.5
Changes From Baseline (Cmax) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel No Intervention	123.0 ng/dL Standard Deviation 85.3

PRIMARY outcome

Timeframe: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

Population: includes female participants that had measurements at the specified timepoints

Evaluate in female participants by assessing changes from baseline up to 48 hours for serum Nestorone levels in Cmin after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.

Outcome measures

Outcome measures
Measure	Nestorone (NES) + Testosterone (T) Combined Gel n=13 Participants A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
Changes From Baseline (Cmin) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel Baseline	0 pg/dL Standard Deviation 0
Changes From Baseline (Cmin) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel With T-shirt Clothing Barrier	0 pg/dL Standard Deviation 0
Changes From Baseline (Cmin) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel Shower and Dried	0 pg/dL Standard Deviation 0
Changes From Baseline (Cmin) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel No Intervention	0 pg/dL Standard Deviation 0

PRIMARY outcome

Timeframe: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

Population: includes female participants that had measurements at the specified timepoints

Evaluate in female participants by assessing changes from baseline up to 48 hours for serum Nestorone levels in Cmax after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.

Outcome measures

Outcome measures
Measure	Nestorone (NES) + Testosterone (T) Combined Gel n=13 Participants A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
Changes From Baseline (Cmax) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel Baseline	0 pg/dL Standard Deviation 0
Changes From Baseline (Cmax) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel With T-shirt Clothing Barrier	4.19 pg/dL Standard Deviation 15.10
Changes From Baseline (Cmax) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel Shower and Dried	3.60 pg/dL Standard Deviation 10.07
Changes From Baseline (Cmax) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel No Intervention	29.3 pg/dL Standard Deviation 35.5

PRIMARY outcome

Timeframe: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

Population: includes female participants that had measurements at the specified timepoints

Evaluate in female participants by assessing changes from baseline up to 48 hours for serum Nestorone levels in Cavg after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.

Outcome measures

Outcome measures
Measure	Nestorone (NES) + Testosterone (T) Combined Gel n=13 Participants A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
Changes From Baseline (Cavg) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel Baseline	0 pg/dL Standard Deviation 0
Changes From Baseline (Cavg) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel With T-shirt Clothing Barrier	0.97 pg/dL Standard Deviation 3.51
Changes From Baseline (Cavg) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel Shower and Dried	0.47 pg/dL Standard Deviation 1.51
Changes From Baseline (Cavg) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel No Intervention	8.12 pg/dL Standard Deviation 10.91

SECONDARY outcome

Timeframe: Baseline and 24 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

Population: Subjects that had measurements at the respective timepoints were included

PK of testosterone in males after wearing a T shirt and after washing will be compared to serum testosterone PK after application of the combined gel without washing using AUC (0-t, where t is the last time-point with measurable concentration)

Outcome measures

Outcome measures
Measure	Nestorone (NES) + Testosterone (T) Combined Gel n=13 Participants A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
PK of T in Males After NES/T With a T-shirt and After Washing With T-shirt Clothing Barrier	16039.71 ng/dL Standard Deviation 6740.37
PK of T in Males After NES/T With a T-shirt and After Washing Shower and Dried	14297.19 ng/dL Standard Deviation 5539.57
PK of T in Males After NES/T With a T-shirt and After Washing No Intervention	15268.13 ng/dL Standard Deviation 5024.31

SECONDARY outcome

Timeframe: Baseline and 24 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)

Population: Subjects that had measurements at the respective timepoints were included

PK of Nestorone in males after wearing a T shirt and after washing will be compared to serum Nestorone PK after application of the combined gel without washing using AUC (0-t, where t is the last time-point with measurable concentration)

Outcome measures

Outcome measures
Measure	Nestorone (NES) + Testosterone (T) Combined Gel n=13 Participants A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
PK of NES in Males After NES/T With a T-shirt and After Washing With T-shirt Clothing Barrier	5376.41 pg/dL Standard Deviation 6730.65
PK of NES in Males After NES/T With a T-shirt and After Washing Shower and Dried	1913.47 pg/dL Standard Deviation 2178.22
PK of NES in Males After NES/T With a T-shirt and After Washing No Intervention	4550.17 pg/dL Standard Deviation 4448.20

SECONDARY outcome

Timeframe: Visits 5 and 7 (Days 8 and 15)

Population: Subjects that had measurements at the respective timepoints were analyzed

Average testosterone levels 90 and 150 minutes after each application in men (over a 15 day period) as measured by adhesive D-square strips with showering (Visit 5) and without showering (Visit 7).

Outcome measures

Outcome measures
Measure	Nestorone (NES) + Testosterone (T) Combined Gel n=13 Participants A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
Average Testosterone Levels 90 and 150 Minutes After Each Application in Men Visit 5, 90 min (With Shower)	17.39 T (microg) Standard Deviation 8.85
Average Testosterone Levels 90 and 150 Minutes After Each Application in Men Visit 5, 150 min (With Shower)	0.24 T (microg) Standard Deviation 0.44
Average Testosterone Levels 90 and 150 Minutes After Each Application in Men Visit 7, 90 min (Without Shower)	17.69 T (microg) Standard Deviation 13.58
Average Testosterone Levels 90 and 150 Minutes After Each Application in Men Visit 7, 150 min (Without Shower)	8.23 T (microg) Standard Deviation 7.10

SECONDARY outcome

Timeframe: Visits 5 and 7 (Days 8 and 15)

Population: Subjects that had measurements at the respective timepoints were analyzed

Average Nestorone levels 90 and 150 minutes after each application in men (over a 15 day period) as measured by adhesive D-square strips with showering (Visit 5) and without showering (Visit 7).

Outcome measures

Outcome measures
Measure	Nestorone (NES) + Testosterone (T) Combined Gel n=13 Participants A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
Average Nestorone Levels 90 and 150 Minutes After Each Application in Men Visit 7, 150 min (Without Shower)	1.03 NES (microg) Standard Deviation 0.99
Average Nestorone Levels 90 and 150 Minutes After Each Application in Men Visit 5, 90 min (With Shower)	2.19 NES (microg) Standard Deviation 1.30
Average Nestorone Levels 90 and 150 Minutes After Each Application in Men Visit 5, 150 min (With Shower)	0.04 NES (microg) Standard Deviation 0.08
Average Nestorone Levels 90 and 150 Minutes After Each Application in Men Visit 7, 90 min (Without Shower)	1.98 NES (microg) Standard Deviation 1.52

SECONDARY outcome

Timeframe: 31 days

Male AEs

Outcome measures

Outcome measures
Measure	Nestorone (NES) + Testosterone (T) Combined Gel n=13 Participants A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
Incidence of Adverse Events and Serious Adverse Events for Males	1 Participants

SECONDARY outcome

Timeframe: 31 days

Female AEs