title: An open-label study of subdermal implants of estradiol-only versus subdermal implants of estradiol plus nomegestrol acetate: effects on symptom control, lipid profile and tolerability.
abstract: OBJECTIVE
  To compare the effects of continuous 17-beta estradiol-only silastic implants with those of continuous 17-beta estradiol plus continuous nomegestrol acetate silastic implants on symptom control, lipid profile and tolerability in postmenopausal women.
  
  
  METHODS
  This was an open-label, parallel-group study. Women with and without uterus and no contraindications to hormone therapy (HT) in this study, we consider as HT the replacement of Estrogens-only and Estrogens + Progestogens Therapy, were enrolled. Each subject was assigned to receive four 17-beta estradiol-only silastic implants (women without uterus), or four 17-beta estradiol plus one nomegestrol acetate silastic implant (women with intact uterus), for 1 year.
  
  
  RESULTS
  A total of 40 subjects were enrolled and received, the silastic implants of which 40 (100.0%) subjects completed the study (n = 20, estradiol only; n = 20, estradiol plus nomegestrol acetate). The incidence of postmenopausal symptoms decreased significantly. No significant decreases in total cholesterol (1.3%), low-density lipoprotein cholesterol (1.1%), triglycerides (1.2%) and fasting glucose ((1.3%) serum levels were observed in both groups, whereas high-density lipoprotein (HDL) cholesterol increased significantly (2.8%), during the study in both groups. The incidences of adverse events were similar in both treatment groups.
  
  
  CONCLUSIONS
  Women treated with 17-beta estradiol-only silastic implants or 17-beta estradiol plus nomegestrol acetate silastic implants showed significant improvement of postmenopausal symptoms, including urogenital and sexual health symptoms and a significant increase in HDL cholesterol and no significant differences in other lipid profiles and tolerability.
authors.affiliation: Maternidade Climério de Oliveira, Teaching Hospital, Federal University of Bahia, Bahia, Brazil. barbosaic@terra.com.br
authors.forename: Ione Cristina
authors.initials: IC
authors.lastname: Barbosa
authors.forename: Elsimar Metzker
authors.initials: EM
authors.lastname: Coutinho
authors.forename: Ladipo
authors.initials: L
authors.lastname: Oladapo
authors.forename: Cristina Fernandes
authors.initials: CF
authors.lastname: Noronha
authors.forename: Regina Lucia Santos
authors.initials: RL
authors.lastname: Mota
authors.forename: Antonio Carlos Vieira
authors.initials: AC
authors.lastname: Lopes
authors.forename: Renata Cruz
authors.initials: RC
authors.lastname: Lopes
mesh_terms: D020405:Dermis; D004129:Dimethylpolysiloxanes; D004343:Drug Implants; D004359:Drug Therapy, Combination; D004414:Dyspareunia / Q000188:drug therapy; D004958:Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D015914:Estrogen Replacement Therapy / Q000379:methods*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D008055:Lipids / Q000097:blood*; D008535:Megestrol / Q000008:administration & dosage* / Q000009:adverse effects; D008598:Menstruation / Q000187:drug effects; D008875:Middle Aged; D009649:Norpregnadienes / Q000008:administration & dosage* / Q000009:adverse effects; D014623:Vaginal Diseases / Q000188:drug therapy; D015430:Weight Gain / Q000187:drug effects
chemical_list: D004129:Dimethylpolysiloxanes; D004343:Drug Implants; D008055:Lipids; D009649:Norpregnadienes; D004958:Estradiol; C013830:baysilon; C038501:nomegestrol acetate; D008535:Megestrol