This is a two-center, open-label study conducted in healthy male and female volunteers at two academic research centers. The study will consist of three single applications of the Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male participants followed 2 hours later by supervised skin contact by the non-dosed female participants on the application site on days 1, 8, and 15. Effect of Washing or Clothing Barrier to the Application will be assessed.
This is a two-center, open-label study conducted in healthy male and female volunteers at two academic research centers. The study will consist of three single applications of the Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male participants followed 2 hours later by supervised skin contact by the non-dosed female participants on the application site on days 1, 8, and 15. On day 1, the male participant will wear a 100% cotton T-shirt over the application area before skin contact with the female. On day 8, the male participant will shower approximately 1 hour and 45 minutes after gel application and engage in skin contact with the female participant (2 hours after gel application) after washing the area with soap and water then drying it. A measurement of residual Nestorone and testosterone will be taken from the male's skin on a single location of the application site using adhesive D-square strips 90 minutes after application (30 minutes before shower/90 minutes after gel application) and 30 minutes after the shower and rubbing (150 minutes after application). On day 15, there will be no shower or clothing barrier for the male participant before skin contact with the female participant. A measurement of residual Nestorone and testosterone will be taken from a single location of the application using adhesive D-square strips site 90 minutes and 150 minutes after the application. An end of study/exit visit will occur for both male and female participants two weeks after treatment completion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
26
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).
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States
University of Washington Medical Center & Health Sciences
Seattle, Washington, United States
Changes From Baseline (Cavg) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
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.
Time frame: 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)
Changes From Baseline (Cmin) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
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.
Time frame: 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)
Changes From Baseline (Cmax) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
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.
Time frame: 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)
Changes From Baseline (Cmin) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
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.
Time frame: 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)
Changes From Baseline (Cmax) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
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.
Time frame: 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)
Changes From Baseline (Cavg) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
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.
Time frame: 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)
PK of T in Males After NES/T With a T-shirt and After Washing
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)
Time frame: 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)
PK of NES in Males After NES/T With a T-shirt and After Washing
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)
Time frame: 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)
Average Testosterone Levels 90 and 150 Minutes After Each Application in Men
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).
Time frame: Visits 5 and 7 (Days 8 and 15)
Average Nestorone Levels 90 and 150 Minutes After Each Application in Men
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).
Time frame: Visits 5 and 7 (Days 8 and 15)
Incidence of Adverse Events and Serious Adverse Events for Males
Male AEs
Time frame: 31 days
Incidence of Adverse Events and Serious Adverse Events for Females
Female AEs
Time frame: 31 days
Changes From Baseline in Hematology Safety Labs for Females
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Changes from baseline in hematology parameters for females measured at Screening (Day -28 to 0) and Visit 7 (Day 15)
Time frame: Screening and Visit 7, up to 43 days
Changes From Baseline in Hematology Safety Labs for Males
Changes from baseline in hematology parameters for males measured at Screening (Day -28 to 0) and Visit 7 (Day 15)
Time frame: Screening and Visit 7, up to 43 days
Changes From Baseline in Clinical Chemistry Safety Labs for Females
Changes from baseline in clinical chemistry parameters for females measured at Screening (Day -28 to 0) and Visit 7 (Day 15)
Time frame: Screening and Visit 7, up to 43 days
Changes From Baseline in Clinical Chemistry Safety Labs for Males
Changes from baseline in clinical chemistry parameters for males measured at Screening (Day -28 to 0) and Visit 7 (Day 15)
Time frame: Screening and Visit 7, up to 43 days
Percentage of Females With Increased (Relative to Baseline) Hirsutism at Each Visit.
Female hirsutism changes assessed at Screening, Visits 4, 6, 8, and 9
Time frame: Screening, Visit 4 (Day 3), Visit 6 (Day 10), Visit 8 (Day 17), and Visit 9 (Day 31)
Percentage of Females With Increased (Relative to Baseline) Acne at Each Visit.
Female acne changes assessed at Screening, Visits 4, 6, 8, and 9
Time frame: Screening, Visit 4 (Day 3), Visit 6 (Day 10), Visit 8 (Day 17), and Visit 9 (Day 31)