title: Postmenopausal uterine bleeding profiles with two forms of continuous combined hormone replacement therapy.
abstract: OBJECTIVE
  This study was designed to compare the bleeding profiles of conjugated equine estrogens 0.625 mg in combination with 2.5 mg medroxyprogesterone acetate (Prempro; CEE/MPA group), the most widely prescribed continuous combined hormone replacement therapy (CCHRT) in the United States, with 17beta-estradiol 1 mg combined with 0.5 mg norethindrone acetate (Activella; E(2)/NETA group), a newly available CCHRT preparation, over a 6-month period.
  
  
  METHODS
  This study was a prospective, randomized, multicenter, double-blind, controlled trial. A total of 438 healthy postmenopausal women were randomized and received treatment (Activella n = 217, Prempro n = 221). Each woman recorded bleeding diaries daily. Total cholesterol, triglycerides, and endometrial biopsies were obtained at screening and end-of-trial visits.
  
  
  RESULTS
  The more favorable bleeding profile was found in the E(2)/NETA (Activella) group. The differences in bleeding patterns were most marked in the first 3 months of treatment in women who were 1-2 years from last menses, with no bleeding in 71.4% vs. 40.0%; ( p = 0.005) and with no bleeding and no spotting in 54.8% vs. 17.1%; (p = 0.001). Triglycerides fell by 8.5% in the E(2)/NETA group and increased by 11.7% in the CEE/MPA group (p < 0.001). Total cholesterol declined by 9.1% and 6.9%, respectively.
  
  
  CONCLUSIONS
  The most important factor in the continuation of HRT is uterine bleeding. E(2)/NETA has significantly less bleeding than the most commonly prescribed CCHRT CEE/MPA, therefore; E(2)/NETA should be associated with improved continuation rates. The patient taking E(2)/NETA will receive effective treatment for her menopausal symptoms with less bleeding.
authors.affiliation: Department of Obstetrics and Gynecology, University of Vermont College of Medicine, Burlington, VT 05405, USA. julia.johnson@vtmednet.org
authors.forename: Julia V
authors.initials: JV
authors.lastname: Johnson
authors.forename: Michael
authors.initials: M
authors.lastname: Davidson
authors.forename: David
authors.initials: D
authors.lastname: Archer
authors.forename: Gloria
authors.initials: G
authors.lastname: Bachmann
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects; D015914:Estrogen Replacement Therapy / Q000379:methods*; D004967:Estrogens / Q000008:administration & dosage / Q000009:adverse effects*; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000009:adverse effects; D017698:Postmenopause / Q000187:drug effects; D011372:Progestins / Q000008:administration & dosage / Q000009:adverse effects*; D014592:Uterine Hemorrhage / Q000139:chemically induced*
chemical_list: D004338:Drug Combinations; D004967:Estrogens; D004966:Estrogens, Conjugated (USP); D011372:Progestins; D004958:Estradiol; D017258:Medroxyprogesterone Acetate; D009640:Norethindrone