Study identification

EU PAS number

EUPAS106503

Study ID

106504

Official title and acronym

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.

DARWIN EU® study

No

Study countries

France
Germany
Hungary
Italy
Poland
United Kingdom

Study description

The impact of contraception on health-related quality of life and the efficacy of the contraceptive method in reproductive-aged women is an important determinant in contraception choice and adherence with contraception methods. The primary goal of this study is to assess the quality of life of women using E4/DRSP, using the questionnaire developed by the Sociedad Española de Contracepción quality of life (SEC-QoL). 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. Participants must be prescribed E4/DRSP by a healthcare professional and must initiate E4/DRSP up to 4 weeks after the baseline visit. Study assessments, including the SEC-QoL, will be taken at baseline, 3-months, and 6-months. After the baseline visit, study assessments will be remotely administered. The Spanish version of the SEC-QoL questionnaire will be translated through a process that ensures linguistic validity into English. The English version will then be translated through the same process that ensures linguistic validity into the appropriate target languages including German, French, Hungarian, Italian, and Polish. Participant-reported data on demographics, medical history, concomitant medications, contraception use, and the SEC-QoL questionnaire will be collected at the baseline visit via an electronic case report form (eCRF). During subsequent study assessments at 3- and 6-months, the SEC-QoL questionnaire, pregnancy information, concomitant medications, study status, other forms of contraception utilised, and adherence, will be collected using the participant-reported ePRO module. AEs will be reported at any time by the participant using the ePRO module.

Study status

Ongoing
Research institutions and networks

Institutions

Gedeon Richter
First published:
01/02/2024
Institution

Contact details

Sydney Willis

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Gedeon Richter
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable