title: Effectiveness, tolerability and acceptance of an oral estradiol/levonorgestrel formulation for the treatment of menopausal complaints: a non-interventional observational study over six cycles of 28 days.
abstract: BACKGROUND
  Use of hormone therapy for menopausal complaints is a subject of controversy and increased uncertainty and concerns. This non-interventional study aimed to investigate a marketed oral formulation containing 1 mg estradiol and 0.04 mg levonorgestrel for continuous treatment of menopausal symptoms for approximately 6 months in women visiting gynecological practices in Germany.
  
  
  METHODS
  Changes in the menopause rating scale (MRS) total and sub-domain scores after three and six 28-d cycles served as primary endpoint. Skin- and hair-related complaints, quality of sexual life and subjective satisfaction with the treatment were assessed. Adverse drug reactions (ADRs), adverse events (AEs) and vaginal bleeding were evaluated.
  
  
  RESULTS
  MRS scores improved significantly above 5 points of clinical relevance as compared to baseline (n = 736, p < 0.0001). Skin- and hair-related symptoms abated; quality of sexual life improved. AEs were registered in 9.9% of the participants. No unexpected ADRs were reported. Bleeding episodes consistently decreased; >75% of the subjects were amenorrheic throughout the study. Medication's effectiveness and tolerability was rated very good/good by >80% of the participants, who also continued treatment.
  
  
  CONCLUSIONS
  This estradiol/low-dose levonorgestrel formulation safely alleviates menopausal symptoms in peri- and postmenopausal women with add-on benefits regarding dermatological and sexual life complaints.
authors.affiliation: Medical Affairs, Jenapharm GmbH & Co. KG , Jena , Germany.
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: D000328:Adult; D000368:Aged; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004967:Estrogens / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D005858:Germany; D020249:Hormone Replacement Therapy / Q000379:methods* / Q000523:psychology / Q000592:standards; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D008593:Menopause / Q000187:drug effects / Q000502:physiology* / Q000523:psychology; D008875:Middle Aged; D017060:Patient Satisfaction; D011372:Progestins / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D004967:Estrogens; D011372:Progestins; D004958:Estradiol; D016912:Levonorgestrel
keywords: Estradiol/levonorgestrel; menopausal hormone therapy; menopause; menopause rating scale; non-interventional study