title: Effects of lasofoxifene on the uterus, vagina, and breast in ovariectomized cynomolgus monkeys (Macaca fascicularis).
abstract: OBJECTIVE
  The purpose of this study was to assess the effects of lasofoxifene on the reproductive system in ovariectomized nonhuman primates.
  
  
  METHODS
  This was a 2-year, randomized study. Adult female macaques (Macaca fascicularis) were assigned randomly into 5 groups: ovariectomized, placebo-treated controls (n = 22); sham-ovariectomized, placebo-treated controls (n = 24); ovariectomized animals given 0.021 mg Premarin kg/d (conjugated equine estrogen; n = 25); lasofoxifene at 1.0 mg/kg/d (n = 23); or lasofoxifene at 5.0 mg/kg/d (n = 25). Outcomes included organ weights and histopathologic findings.
  
  
  RESULTS
  Lasofoxifene did not increase uterine weight or endometrial thickness and did not change mammary, vaginal, or cervical histologic condition. Mild endometrial fibrosis and cystic change were seen in lasofoxifene-treated animals, in contrast to significant uterine weight increases and endometrial hyperplasia induced by conjugated equine estrogen.
  
  
  CONCLUSIONS
  Lasofoxifene did not increase uterine weight and produced minor histologic uterine changes at the doses that were given and had no effect on the breast, vagina, or cervix.
authors.affiliation: Department of Pathology, Comparative Medicine, Wake Forest University Health Sciences, Winston-Salem, NC 27157-1040, USA. jmcline@wfubmc.edu
authors.forename: J Mark
authors.initials: JM
authors.lastname: Cline
authors.forename: Suzanne
authors.initials: S
authors.lastname: Botts
authors.forename: Cynthia J
authors.initials: CJ
authors.lastname: Lees
authors.forename: Robert
authors.initials: R
authors.lastname: Brommage
mesh_terms: D000818:Animals; D001940:Breast / Q000187:drug effects*; D002584:Cervix Uteri / Q000187:drug effects; D004717:Endometrium / Q000187:drug effects / Q000473:pathology; D005260:Female; D005355:Fibrosis; D008252:Macaca fascicularis; D009929:Organ Size / Q000187:drug effects; D010052:Ovariectomy; D011759:Pyrrolidines / Q000494:pharmacology*; D013764:Tetrahydronaphthalenes / Q000494:pharmacology*; D014599:Uterus / Q000187:drug effects*; D014621:Vagina / Q000187:drug effects*
chemical_list: D011759:Pyrrolidines; D013764:Tetrahydronaphthalenes; C111332:Lasofoxifene