CARE4HER
Research type
Research Study
Full title
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
IRAS ID
327364
Contact name
Paula Briggs
Contact email
Sponsor organisation
Gedeon Richter Plc
Clinicaltrials.gov Identifier
EUPAS106503, www.encepp.eu
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This study is an observational, prospective, single-arm, international multi-centre, open-label Phase 4 study to assess QoL using the SEC-QoL, adherence, and clinical safety and tolerability of E4/DRSP in women aged 16 or older without contraindications for E4/DRSP and to linguistically validate the SEC-QoL. The purpose of this observational study is to assess the quality of life of women who are prescribed with DROVELIS® (estetrol (14.2 mg)/ drospirenone (3 mg)) for contraception, particularly focussing on the menstrual and breast associated symptoms. The study will also assess drug efficacy, safety, and tolerability.
DROVELIS® is a hormonal contraceptive which is approved and marketed in the European Union and the UK. It can only be obtained with a prescription and comes in blisters containing 28 tablets (24 “active” tablets” and 4 “inactive” tablets that do not contain the active substance).
An observational study is research that aims to collect data over time on how a certain treatment is used and its effects, without any change to normal care. This means that routine clinical practice is followed. Any treatment given follows normal routine and is decided by the study doctor. This study will not alter or interfere with the normal care in any way.REC name
South Central - Oxford B Research Ethics Committee
REC reference
24/SC/0072
Date of REC Opinion
26 Feb 2024
REC opinion
Favourable Opinion