Non-interventional Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction (Mirabel)

Bayer

Status: Completed

Conditions: Contraception

Treatments: Device: Copper IUD; Drug: Levonorgestrel (Mirena, BAY86-5028)

Study type: Observational

Funder types: Industry

Identifiers

NCT01590537

MA1010RU (Other Identifier)

15508

Details and patient eligibility

About

This is local prospective, non-interventional multi-center comparative study. Primary study objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after insertion ( patient assessment questionnaire) in daily practice. For each patient, the treating gynecologist documents demographics, medical data, safety parameters and treatment signs and symptoms at an initial visit and one or two follow-up visit(s).

Enrollment: 2,348 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women 20-40 years old
• Parity ≥ 1 child
• Requesting long-term contraception
• Written informed consent.

Exclusion criteria

• in accordance with the current leaflet

Trial design

2,348 participants in 2 patient groups

Group 1

Treatment:

Drug: Levonorgestrel (Mirena, BAY86-5028)

Group 2

Treatment:

Device: Copper IUD