KYleena Satisfaction Study / Observational Study on User Satisfaction With the Levonorgestrel Intrauterine Delivery System Kyleena (LNG-IUS 12) in New Contraceptive Users and After Switching From Another Contraceptive Method (KYSS)

Bayer

Status: Completed

Conditions: Contraception

Treatments: Drug: Kyleena

Study type: Observational

Funder types: Industry

Identifiers

NCT03182140

19186

Details and patient eligibility

About

The main goal of this non-interventional study (NIS) is to evaluate user satisfaction with Kyleena in a real-life setting and to identify factors which influence user satisfaction, taking into account previously used contraceptive methods and reasons for use of Kyleena.

Enrollment: 1,134 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women requesting contraception with Kyleena. The woman's informed decision for contraception with Kyleena was made before and independently from the study as per investigator's routine practice
• Written informed consent.

Exclusion criteria

• Contraindications for Kyleena according to the local market authorization/SmPC
• Mental incapacity to consent and provide data during the observational study
• Women participating in an investigational program with interventions outside of routine clinical practice.

Trial design

1,134 participants in 1 patient group

Kyleena

Description:

Non-interventional, observational, uncontrolled study in women that have chosen Kyleena as their contraceptive method before entering the study

Treatment:

Drug: Kyleena