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
- Conditions
- Male ContraceptionHealthy MenHealthy WomenProduct Transference
- Interventions
- Registration Number
- NCT02994602
- Lead Sponsor
- Health Decisions
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nestorone (NES) + testosterone (T) combined gel Nestorone + Testosterone Combination 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.
- Primary Outcome Measures
Name Time Method 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 17 days female serum testosterone changes in cmax
Evaluate in female participants by assessing Nestorone levels after secondary exposure to NES/T by presenting Cmin 17 days female nestorone levels in cmin
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 17 days female serum testosterone changes in cmin
Evaluate in female participants by assessing Nestorone levels after secondary exposure to NES/T by presenting Cavg 17 days female nestorone levels in cavg
Evaluate in female participants by assessing Nestorone levels after secondary exposure to NES/T by presenting Cmax 17 days female nestorone levels in cmax
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 17 days female serum testosterone changes in cavg
- Secondary Outcome Measures
Name Time Method 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) 15 days PK of NES in males after NES/T with a T-shirt and after washing
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 and without showering. 15 days T levels compared with and without showering
Changes from baseline in safety labs for males 31 days Female lab changes
Incidence of adverse events and serious adverse events for males 31 days Male AEs
Percentage of females with increased (relative to baseline) acne at each visit. 31 days Female acne changes
PK of serum testosterone in males after applying NES/T gel with or without T shirt and with washing will be compared to baseline serum testosterone 15 days male changes in serum T compared to baseline
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 and without showering. 15 days NES levels compared with and without showering
Percentage of females with increased (relative to baseline) hirsutism at each visit. 31 days Female hirsutism changes
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) 15 days PK of T in males after NES/T with a T-shirt and after washing
Incidence of adverse events and serious adverse events for females 31 days Female AEs
Trial Locations
- Locations (2)
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