title: Phase III randomized double-blind study to evaluate the efficacy of a polycarbophil-based vaginal moisturizer in women with breast cancer.
abstract: OBJECTIVE
  Vaginal dryness and dyspareunia are significant estrogen-depletion symptoms that affect many breast cancer survivors. The present trial was developed to evaluate the nonhormonal vaginal lubricating preparation, Replens, for alleviating these symptoms.
  
  
  METHODS
  A double-blind, crossover, randomized clinical trial was developed. Patients received 4 weeks of Replens (Columbia Research Laboratories, Rockville Centre, NY) followed by a 1-week washout period followed by 4 weeks of a placebo lubricating product, or vice versa. Weekly patient-completed diaries were used for measuring efficacies and toxicities of therapy.
  
  
  RESULTS
  The 45 assessable patients provided well-balanced treatment groups. During the first 4 weeks, average vaginal dryness decreased by 62% and 64% in the placebo and Replens groups, respectively (P = .3). Average dyspareunia scores also improved by 41% and 60%, respectively (P = .05). Crossover analysis indicated that the bulk of the beneficial effects appeared within the first 2 weeks of the first treatment and remained constant thereafter. Both treatments were relatively well tolerated.
  
  
  CONCLUSIONS
  Both Replens and the placebo appear to substantially ameliorate vaginal dryness and dyspareunia in breast cancer survivors.
authors.affiliation: Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA. cloprinzi@mayo.edu
authors.forename: C L
authors.initials: CL
authors.lastname: Loprinzi
authors.forename: S
authors.initials: S
authors.lastname: Abu-Ghazaleh
authors.forename: J A
authors.initials: JA
authors.lastname: Sloan
authors.forename: C
authors.initials: C
authors.lastname: vanHaelst-Pisani
authors.forename: A M
authors.initials: AM
authors.lastname: Hammer
authors.forename: K M
authors.initials: KM
authors.lastname: Rowland
authors.forename: M
authors.initials: M
authors.lastname: Law
authors.forename: H E
authors.initials: HE
authors.lastname: Windschitl
authors.forename: J S
authors.initials: JS
authors.lastname: Kaur
authors.forename: N
authors.initials: N
authors.lastname: Ellison
mesh_terms: D000328:Adult; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004414:Dyspareunia / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008153:Lubrication; D008875:Middle Aged; D014621:Vagina / Q000187:drug effects* / Q000378:metabolism; D014622:Vaginal Creams, Foams, and Jellies / Q000627:therapeutic use*
chemical_list: D014622:Vaginal Creams, Foams, and Jellies