title: Effect on quality of life of switching to combined oral contraception based on natural estrogen: an observational, multicentre, prospective phase IV study (ZOCAL Study).
abstract: OBJECTIVE
  This observational, multicentre, prospective phase IV study examined change in health-related quality of life (QOL) from baseline to 6 months in women initiating combined oral contraception (COC) based on natural estrogen.
  
  
  METHODS
  Eligible women attending a baseline and 6-month gynaecology appointment belonged to one of three groups: group 1 used barrier contraception (condoms) and elected to continue this method; group 2 used condoms and elected to switch to COC based on natural estrogen; group 3 used COC based on ethinylestradiol and elected to switch to COC based on natural estrogen. The Spanish Society of Contraception (SEC)-QOL scale assessed health-related QOL. Secondary outcomes included symptoms of premenstrual syndrome, intermenstrual bleeding, duration and intensity of menstrual bleeding, contraception continuation rate, and tolerability.
  
  
  RESULTS
  A total of 857 women were enrolled and 785 completed the study. Group 2 (n = 224 completed) had significantly lower SEC-QOL global and dimension scores at baseline and significantly greater increases in SEC-QOL from baseline to 6 months compared with groups 1 (n = 72) and 3 (n = 489). Group 3 reported a similar SEC-QOL score to that of group 1 at baseline but showed significantly greater improvement in SEC-QOL global and psychological scores from baseline to 6 months. Among women receiving COC based on natural estrogen, the contraception continuation rate was 713/780 (91.4%); treatment-related adverse events were reported by 13/780 (1.7%).
  
  
  CONCLUSIONS
  Improved SEC-QOL after 6 months was found in women who were dissatisfied with their current contraception at baseline and chose to switch to COC based on natural estrogen.
authors.affiliation: a Department of Obstetrics and Gynaecology , Araba University Hospital , Vitoria-Gasteiz , Spain ;
authors.forename: Iñaki
authors.initials: I
authors.lastname: Lete
authors.affiliation: b Department of Obstetrics and Gynaecology , University Hospital of Guadalajara , Guadalajara , Spain ;
authors.forename: Esther
authors.initials: E
authors.lastname: de la Viuda
authors.affiliation: c Department of Obstetrics and Gynaecology , Hospital General de Requena , Valencia , Spain ;
authors.forename: Ezequiel
authors.initials: E
authors.lastname: Pérez-Campos
authors.affiliation: d Centro de Salud Sexual y Reproductiva Alicante III , Alicante , Spain ;
authors.forename: María Ángeles Gómez
authors.initials: MÁ
authors.lastname: Martínez
authors.affiliation: e Teva Pharma Medical Affairs , Madrid , Spain ;
authors.forename: Rainel
authors.initials: R
authors.lastname: Sanchez-de la Rosa
authors.affiliation: e Teva Pharma Medical Affairs , Madrid , Spain ;
authors.forename: Jesús
authors.initials: J
authors.lastname: Novalbos
authors.affiliation: f DIATROS, Clínica de Atención a la Mujer , Barcelona , Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Sánchez-Borrego
mesh_terms: D000293:Adolescent; D000328:Adult; D017280:Condoms / Q000706:statistics & numerical data; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects / Q000627:therapeutic use*; D004997:Ethinyl Estradiol / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008535:Megestrol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008796:Metrorrhagia / Q000139:chemically induced; D008875:Middle Aged; D009277:Nandrolone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D017060:Patient Satisfaction; D011293:Premenstrual Syndrome / Q000139:chemically induced; D011446:Prospective Studies; D011788:Quality of Life; D055815:Young Adult
chemical_list: D003277:Contraceptives, Oral, Combined; C047637:nomegestrol; D004997:Ethinyl Estradiol; C023635:dienogest; D009277:Nandrolone; D008535:Megestrol
keywords: Combined oral contraception; E2V/DNG; NOMAC/E2; natural estrogen; quality of life