title: Serum testosterone levels in non-dosed females after secondary exposure to 1.62% testosterone gel: effects of clothing barrier on testosterone absorption.
abstract: OBJECTIVE
  To evaluate secondary exposure of testosterone transferred to females from a male partner, dosed with 1.62% testosterone gel after direct skin-to-skin contact with the application site, and to investigate the effect of wearing a t-shirt on testosterone transfer.
  
  
  METHODS
  Across three studies, a total of 72 healthy males applied 5.0 g 1.62% testosterone gel to their abdomen alone, upper arms/shoulders alone, or a combination of their upper arms/shoulders and abdomen (single dose or once daily for 7 days). Male-female contact occurred 2 or 12 hours after testosterone gel application, with males either wearing or not wearing a t-shirt. There were 15 minutes of supervised contact with the application site between the male and his female partner. Blood samples were collected over a 24 hour period in females for assessment of serum testosterone levels at baseline and after contact.
  
  
  METHODS
  Pharmacokinetic parameters included C(max) (maximum serum concentration), AUC(0-24) (area under the serum concentration-time curve from 0-24 hours), and C(av) (time-averaged concentration over the 24-hour period post-contact). Subjects were monitored for adverse events. CLINICAL TRIAL REGISTRATION NCT NUMBERS: Study 1 was not registered (first subject enrolled 8 March 2007); Study 2: 00998933; Study 3, 01130298.
  
  
  RESULTS
  Testosterone levels (C(av) and C(max)) in females increased 86-185% from baseline after direct abdominal skin contact, although C(av) levels remained within female eugonadal range. Testosterone concentrations returned to baseline within 48 hours after last skin contact. A t-shirt barrier reduced testosterone transfer by approximately 40-48% when 5.0 g of testosterone gel was applied to the abdomen alone. A t-shirt barrier prevented transfer when 5.0 g of testosterone gel was applied to the upper arms and shoulders or to a combination of the upper arms and shoulders and the abdomen (C(max) and C(av) increased by approximately 5-11%). No major safety events were observed during the studies.
  
  
  CONCLUSIONS
  There is a risk of testosterone transfer from males using 1.62% testosterone gel to others who come in contact with the application site for at least 12 hours after application. Secondary exposure can be mitigated by means of a t-shirt barrier.
  
  
  CONCLUSIONS
  Women for these studies were not selected by menopausal status. The study designs were intended to simulate exaggerated conditions of transfer.
authors.affiliation: Abbott, Abbott Park, IL 60064, USA.
authors.forename: Jodi
authors.initials: J
authors.lastname: Stahlman
authors.forename: Margaret
authors.initials: M
authors.lastname: Britto
authors.forename: Sherahe
authors.initials: S
authors.lastname: Fitzpatrick
authors.forename: Cecilia
authors.initials: C
authors.lastname: McWhirter
authors.forename: Samuel A
authors.initials: SA
authors.lastname: Testino
authors.forename: John J
authors.initials: JJ
authors.lastname: Brennan
authors.forename: Troy L
authors.initials: TL
authors.lastname: Zumbrunnen
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D003020:Clothing; D005260:Female; D005782:Gels / Q000008:administration & dosage / Q000627:therapeutic use; D020249:Hormone Replacement Therapy / Q000379:methods*; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D012867:Skin / Q000187:drug effects; D012869:Skin Absorption; D013739:Testosterone / Q000009:adverse effects / Q000097:blood* / Q000493:pharmacokinetics*; D055815:Young Adult
chemical_list: D005782:Gels; D013739:Testosterone