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
Condition: Healthy Men; Male Contraception; Healthy Women; Product Transference
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Nestorone + Testosterone Combination Gel
Intervention type(s): Drug
Intervention description(s): 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).
Other intervention name(s): NES/T gel; NES8/T60
Intervention MeSH terms: ST 1435; Testosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Men; Male Contraception; Healthy Women; Transfer; Transference; Gel; Nestorone; Testosterone