title: Testosterone patch for the treatment of hypoactive sexual desire disorder in naturally menopausal women: results from the INTIMATE NM1 Study.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of a testosterone patch for the treatment of women with hypoactive sexual desire disorder after natural menopause.
  
  
  METHODS
  A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was conducted in naturally menopausal women with hypoactive sexual desire disorder receiving a stable dose of oral estrogen with or without progestin (N = 549). Women were randomized to receive testosterone 300 microg/day or placebo patches twice weekly for 24 weeks. The primary efficacy measure was change from baseline in frequency of total satisfying sexual activity over a 4-week period (weeks 21-24).
  
  
  RESULTS
  A total of 483 women (88%) were included in the primary analysis population (those with baseline sex hormone binding globulin levels < or = 160 nmol/L). The change from baseline in number of total satisfying sexual episodes was significantly greater for testosterone compared with placebo (participants with baseline sex hormone binding globulin levels < or = 160 nmol/L, mean change of 2.1 +/- 0.28 versus 0.5 +/- 0.23 episodes/4 weeks; P < 0.0001; intent-to-treat population, mean change from baseline of 1.9 +/- 0.26 versus 0.5 +/- 0.21 episodes/4 weeks, P < 0.0001). Testosterone also produced statistically significant improvements compared with placebo in all secondary efficacy measures, including sexual desire and personal distress. The testosterone patch was well tolerated.
  
  
  CONCLUSIONS
  Testosterone patch treatment increased the frequency of satisfying sexual activity and sexual desire, decreased personal distress, and was well tolerated in naturally menopausal women with hypoactive sexual desire disorder.
authors.affiliation: Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA 02114, USA. jshifren@partners.org
authors.forename: Jan L
authors.initials: JL
authors.lastname: Shifren
authors.forename: Susan R
authors.initials: SR
authors.lastname: Davis
authors.forename: Michele
authors.initials: M
authors.lastname: Moreau
authors.forename: Arthur
authors.initials: A
authors.lastname: Waldbaum
authors.forename: Celine
authors.initials: C
authors.lastname: Bouchard
authors.forename: Leonard
authors.initials: L
authors.lastname: DeRogatis
authors.forename: Christine
authors.initials: C
authors.lastname: Derzko
authors.forename: Patricia
authors.initials: P
authors.lastname: Bearnson
authors.forename: Norman
authors.initials: N
authors.lastname: Kakos
authors.forename: Sheila
authors.initials: S
authors.lastname: O'Neill
authors.forename: Stephen
authors.initials: S
authors.lastname: Levine
authors.forename: Kathryn
authors.initials: K
authors.lastname: Wekselman
authors.forename: Akshay
authors.initials: A
authors.lastname: Buch
authors.forename: Cynthia
authors.initials: C
authors.lastname: Rodenberg
authors.forename: Robin
authors.initials: R
authors.lastname: Kroll
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000728:Androgens / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008593:Menopause / Q000502:physiology; D008875:Middle Aged; D012725:Sexual Behavior / Q000187:drug effects; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy*; D013739:Testosterone / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000728:Androgens; D013739:Testosterone