title: Effectiveness, tolerability and acceptance of a low-dosed estradiol/dienogest formulation (Lafamme 1 mg/2 mg) for the treatment of menopausal complaints: a non-interventional observational study over 6 cycles of 28 days.
abstract: BACKGROUND
  Concern and controversy characterize nowadays the use of hormone therapy for management of patients with menopausal complaints. This observational non-interventional study examined the use of a marketed oral formulation containing 1 mg estradiol valerate and 2 mg dienogest for treatment of menopausal symptoms in 1292 women visiting 243 gynecological practices in Germany.
  
  
  METHODS
  Score changes in the Menopausal Rating Scale (MRS) after three and six 28-day cycles were primary endpoints. Subjective reports on skin- and hair-related complaints and satisfaction with treatment effects were assessed. The incidence of adverse drug reactions (ADRs), adverse events (AEs) and vaginal bleeding was evaluated.
  
  
  RESULTS
  MRS total score decreased substantially and stronger than the clinically relevant change of 5 points (p < 0.0001) as compared with baseline. Subjective skin- and hair-related complaints declined. No unexpected ADRs were reported. AEs (including ADRs) were registered in 8.8% of the participants; most frequent AEs/ADRs were postmenopausal hemorrhage (2.9%) and drug ineffective (1.4%). Nearly 76% of the subjects remained amenorrheic. Approximately 90% of the patients rated the medication's effectiveness/tolerability as good/very good; 84% intended to continue the treatment.
  
  
  CONCLUSIONS
  This low-dose estradiol/dienogest formulation proved efficient and well-tolerated option for the alleviation of menopausal symptoms associated with estrogen deficiency.
authors.affiliation: a Jenapharm GmbH & Co. KG, Medical Affairs , Jena , Germany and.
authors.forename: Daniela
authors.initials: D
authors.lastname: Rouskova
authors.forename: Katrin
authors.initials: K
authors.lastname: Mittmann
authors.forename: Ulrike
authors.initials: U
authors.lastname: Schumacher
authors.forename: Horst
authors.initials: H
authors.lastname: Dietrich
authors.forename: Thomas
authors.initials: T
authors.lastname: Zimmermann
mesh_terms: D000728:Androgens / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D004967:Estrogens / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D020249:Hormone Replacement Therapy / Q000379:methods*; D006801:Humans; D008593:Menopause / Q000187:drug effects; D008875:Middle Aged; D009277:Nandrolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data*; D063868:Patient Outcome Assessment
chemical_list: D000728:Androgens; D004338:Drug Combinations; D004967:Estrogens; C454300:estradiol valerate-dienogest; D004958:Estradiol; D009277:Nandrolone
keywords: Estrogens; Menopause Rating Scale; hormone replacement therapy; menpopause; progesterone