title: Ospemifene in the treatment of vulvovaginal atrophy.
abstract: OBJECTIVE
  To review the pharmacology, efficacy, and safety of ospemifene in the management of dyspareunia.
  
  
  METHODS
  Literature was sought using PubMed (1966-January 2014) and EMBASE (1973-January 2014). Search terms included ospemifene, FC-1271a, dyspareunia, vulvovaginal atrophy, and vaginal atrophy.
  
  
  METHODS
  All studies, including studies on humans, published in English with data assessing the efficacy and safety of ospemifene in the management of dyspareunia were evaluated.
  
  
  RESULTS
  Ospemifene is a new oral estrogen receptor agonist/antagonist indicated for moderate to severe dyspareunia. Clinical trials evaluating efficacy have shown a significant improvement in superficial cells, parabasal cells, vaginal pH, vaginal dryness, and dyspareunia. The most frequently reported adverse drug reactions in the clinical trials included hot flashes, vaginal discharge, muscle spasms, and hyperhidrosis. Similar to systemic estrogen, boxed warnings with ospemifene include risk for thromboembolism and cerebrovascular disease. Additionally, patients with a uterus still need to use a progestogen with ospemifene to reduce the risk of hyperplasia.
  
  
  CONCLUSIONS
  Ospemifene has been effective in improving symptoms of vulvovaginal atrophy when compared with placebo; however, no studies comparing ospemifene with estrogen products exist. Additional clinical trials are needed to evaluate the efficacy and safety in specialty populations, and long-term safety data are needed to assess the potential for serious adverse events. With the risks being similar to that for systemic estrogen therapy, ospemifene appears to be an alternative agent to estrogen therapy but does not have any advantages over estrogen.
authors.affiliation: University of Missouri Kansas City School of Pharmacy, Kansas City, MO, USA.
authors.forename: Kylie N
authors.initials: KN
authors.lastname: Barnes
authors.forename: Erica F
authors.initials: EF
authors.lastname: Pearce
authors.forename: Abigail M
authors.initials: AM
authors.lastname: Yancey
authors.forename: Alicia B
authors.initials: AB
authors.lastname: Forinash
mesh_terms: D001284:Atrophy / Q000188:drug therapy; D004414:Dyspareunia / Q000188:drug therapy*; D005260:Female; D006801:Humans; D020845:Selective Estrogen Receptor Modulators / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013629:Tamoxifen / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D014621:Vagina / Q000473:pathology*; D014844:Vulva / Q000473:pathology*
chemical_list: D020845:Selective Estrogen Receptor Modulators; D013629:Tamoxifen; C119141:Ospemifene
keywords: dyspareunia; ospemifene; vaginal atrophy; vulvovaginal atrophy