title: Twice-weekly transdermal estradiol and vaginal progesterone as continuous combined hormone replacement therapy in postmenopausal women: a 1-year prospective study.
abstract: OBJECTIVE
  The purpose of this study was to evaluate the acceptability and endometrial safety of a twice-weekly administration of transdermal estradiol (0.05 mg) systems and vaginal progesterone gel (Crinone [Serono, Rome, Italy] 4%, 45 mg/d) as a continuous combined nonoral hormone replacement therapy regimen.
  
  
  METHODS
  Thirty-five postmenopausal women took part in this 1-year prospective observational trial. The bleeding pattern, blood pressure, weight, endometrial thickness, and endometrial histologic characteristics of the women were monitored. Mean values were compared before and after treatment by paired Student t tests.
  
  
  RESULTS
  Twenty-six (74.3%) women completed the study and were totally amenorrheic. A total of 350 cycles yielded valuable data. Of these, 287 (82%) cycles were amenorrheic. At month 3, blood pressure and weight decreased significantly. At final assessment, endometrial thickness was significantly greater than baseline (4.6 +/- 0.9 vs 3.6 +/- 0.9 mm; P <.0005), and histologic examination revealed endometrial atrophy in 24 (92.3%) cases and signs of decidualization in 2 cases.
  
  
  CONCLUSIONS
  Transdermal estradiol and a twice-weekly administration of the vaginal progesterone gel Crinone constitutes a new, viable hormone replacement therapy regimen. It represents a practical option for a no-bleed treatment, ensuring both high endometrial protection and the inherent safety linked to administrating physiologic hormones nonorally.
authors.affiliation: First Institute of Gynecology and Obstetrics, University of Bari, Policlinico, Italy. Cicinelli@gynecology1.uniba.it
authors.forename: Ettore
authors.initials: E
authors.lastname: Cicinelli
authors.forename: Dominique
authors.initials: D
authors.lastname: de Ziegler
authors.forename: Pietro
authors.initials: P
authors.lastname: Galantino
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Pinto
authors.forename: Bruno
authors.initials: B
authors.lastname: Barba
authors.forename: Stella
authors.initials: S
authors.lastname: Morgese
authors.forename: Sergio
authors.initials: S
authors.lastname: Schonauer
mesh_terms: D000279:Administration, Cutaneous; D000282:Administration, Intravaginal; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D004334:Drug Administration Schedule; D004958:Estradiol / Q000008:administration & dosage*; D015914:Estrogen Replacement Therapy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D011374:Progesterone / Q000008:administration & dosage*; D011446:Prospective Studies
chemical_list: D011374:Progesterone; D004958:Estradiol