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:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 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:
  Among the 355 participants who were enrolled in the study, 282 were included in the Safety ; Analysis Set (SAF), 253 were included in the Full Analysis Set, and 215 were included in the ; Follow-up Analysis Set. The mean (SD) age at enrolment was 30.7 (8.65) years. Among all ; participants, the mean (SD) body mass index at enrolment was 23.69 (4.57) kg/m2.; ; At 3-months and 6-months, participants reported a minor increase in QoL for the breast ; domain (Least Squares [LS] mean: 2.3, standard error [SE]: 1.73, p-value: 0.1849 and LS ; mean: 3.2, SE: 1.82, p-value: 0.0762, respectively) and menstrual domain (LS mean: 2.4, SE: ; 1.47, p-value: 0.1096 and LS mean: 2.2, SE: 1.56, p-value: 0.1651, respectively) of the ; SEC-QoL, although not statistically significant nor a meaningful within-patient change ; (MWPC). Descriptively, changes from baseline values for the breast and menstrual domain of ; the SEC-QoL at 3-months and 6-months were stronger among participants ≥35 years ; compared to participants <35 years.; ; Compared to baseline, at 3-months and 6-months, the SEQ-QoL individual items with the ; greatest improvement primarily included items in the psychological domain. At 3-months, ; these items included reduced anxiety of the contraceptive method failing, reduced concern of ; a hormonal disorder, and being less nervous at work when on period. At 6-months, these ; items included reduced concern of a hormonal disorder, reduced anxiety of the contraceptive ; method failing, and less of a reduced desire to have sex during the first few days of the period.; At both 3-months and 6-months, participants reported an overall increased QoL, assessed ; using the SEC-QoL 19-item score. The LS mean (SE) change from baseline at 3-months was ; 3.6 (0.99) (p-value=0.0004). The LS mean (SE) change from baseline at 6-months was ; 3.6 (1.18) (p-value=0.0024)