title: Uterine effects of estrogen plus progestin therapy and raloxifene: adjudicated results from the EURALOX study.
abstract: OBJECTIVE
  To compare the incident rate of abnormal endometrial findings in postmenopausal women receiving treatment with either 60 mg of raloxifene or a continuous combined estrogen plus progestin therapy containing 2 mg of 17 beta-estradiol plus 1 mg of norethisterone acetate for a duration of up to 12 months.
  
  
  METHODS
  One thousand eight asymptomatic postmenopausal women with osteoporosis or cardiovascular risk factors with an endometrial thickness of less than 5 mm at baseline participated in this prospective, randomized, double-blind trial that lasted 6 months; 347 of these women also participated in a 6-month extension. Women with repeated bleeding or an increase in endometrial thickness to above 5 mm were subjected to saline-infused sonohysterography or hysteroscopy with biopsy. Sonographic, histologic, and clinical findings were adjudicated by a panel of 4 experts blinded with respect to patients' treatments. All adjudicated patients were grouped into 15 diagnostic categories according to predefined criteria.
  
  
  RESULTS
  Three hundred thirty-four women needed adjudication during the core phase, 73 (14.7%) of those taking raloxifene and 261 (50.9%) taking continuous combined estrogen plus progestin therapy (P <.001). Compared with raloxifene, women using continuous combined estrogen plus progestin therapy had significantly higher rates of benign endometrial proliferation (8.8 versus 1.2%, P <.001), endometrial polyps (4.3 versus 2.0%, P =.048), and cystic atrophy (5.5 versus 1.2%, P <.001).
  
  
  CONCLUSIONS
  Women using continuous combined estrogen plus progestin therapy more often have benign endometrial pathology and, in our study, more often required the protocol-specific gynecological follow-up assessments for safety reasons, as compared with those using raloxifene. These findings are of clinical relevance when choosing the most appropriate therapy for postmenopausal health risks such as osteoporosis.
authors.affiliation: Department of Gynaecological Oncology, Univesity of Leuven, Leuven, Belgium. Patrick.neven@zu.kuleuven.ac.be
authors.forename: Patrick
authors.initials: P
authors.lastname: Neven
authors.forename: Deborah
authors.initials: D
authors.lastname: Quail
authors.forename: Marc
authors.initials: M
authors.lastname: Lévrier
authors.forename: Fernanda
authors.initials: F
authors.lastname: Aguas
authors.forename: Hok Sien
authors.initials: HS
authors.lastname: Thé
authors.forename: Christian
authors.initials: C
authors.lastname: De Geyter
authors.forename: Michael D
authors.initials: MD
authors.lastname: Glant
authors.forename: Heike
authors.initials: H
authors.lastname: Beck
authors.forename: Brigitte
authors.initials: B
authors.lastname: Bosio-LeGoux
authors.forename: Henri
authors.initials: H
authors.lastname: Schmitt
authors.forename: Antje
authors.initials: A
authors.lastname: Hottgenroth
authors.forename: Thomas
authors.initials: T
authors.lastname: Nickelsen
mesh_terms: D000465:Algorithms; D004311:Double-Blind Method; D004958:Estradiol / Q000627:therapeutic use*; D004967:Estrogens / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009640:Norethindrone / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000077563:Norethindrone Acetate; D011446:Prospective Studies; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use*; D014599:Uterus / Q000187:drug effects*
chemical_list: D004967:Estrogens; D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride; D004958:Estradiol; D000077563:Norethindrone Acetate; D009640:Norethindrone