ContrAceptive Research on E4 – Health Effects on eveRyday wellbeing (CARE4HER): A post-authorisation, observational, single-arm, open-label study to evaluate health-related quality of life using the Sociedad Española de Contracepción Quality of Life Questionnaire in women prescribed estetrol (14.2 mg)/ drospirenone (3 mg) for contraception.

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Health related quality of life
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DROSPIRENONE

  ESTETROL

Population studied

• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
• Special population of interest:
  Women of childbearing potential using contraception
• Estimated number of subjects:
  800

Study design details

• Main study objective:
  To assess in users of E4/DRSP the change from baseline scores at 3- and 6-months in the menstrual and breast domains of the SEC-QoL Questionnaire.
• Outcomes:
  o Change from baseline in the 3-item standardised SEC-QoL questionnaire breast domain score after 3 and 6 months. o Change from baseline in the 4-item standardised SEC-QoL questionnaire menstrual domain score after 3 and 6 months. o Change from baseline in individual SEC-QoL questionnaire standardised item scores after 3 and 6 months o Change from baseline in the overall 19-item standardised SEC-QoL questionnaire score after 3 and 6 months o Assess contraceptive efficacy using the Pearl Index o Proportion of self-reported adherent cycles among all participants o Change from baseline in body weight after 3 and 6 months
• Data analysis plan:
  Scores for the SEC-QoL questionnaire overall and for each domain and the change from baseline in standardised scores will be reported at baseline, the 3-month, and the 6-month follow-up time point summarised by mean, SD, median, first quartile, third quartile, minimum, and maximum. Repeated measures mixed model will be used to formally assess change from baseline to 6 months for each domain using post hoc analyses while adjusting for multiple comparisons (Bonferroni method).
• Summary results:
  Within this study population, at 3-months and 6-months, participants reported a minor increase in both the breast domain and the menstrual domain QoL. Although there were no statistically significant changes nor MWPC at 3-months and 6-months for the SEC-QoL breast and menstrual domains, the SEC-QoL breast and menstrual domain scores were consistent with baseline, with a descriptive trend towards improved QoL. Participants reported an overall increased QoL for individual items on the SEC-QoL primarily for the items in the psychological domain, as well as a statistically significant increase in the combined SEC-QoL score. Importantly, QoL, as measured by the SEC-QoL, was stable over the course of the study, with a trend for improvement. E4/DRSP contraception was well tolerated.