Prospective Multicentre Non-interventional Comparative Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction

Bayer0 sites2,348 target enrollmentSeptember 2011

ConditionsContraception

InterventionsLevonorgestrel (Mirena, BAY86-5028)Copper IUD

DrugsLevonorgestrel (Mirena, BAY86-5028)

Overview

Phase: Not Applicable
Intervention: Levonorgestrel (Mirena, BAY86-5028)
Conditions: Contraception
Sponsor: Bayer
Enrollment: 2348
Primary Endpoint: User satisfaction of the contraception method with Mirena or Copper IUD
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

October 2014

Last Updated

10 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Group 1

Intervention: Levonorgestrel (Mirena, BAY86-5028)

Group 2

Intervention: Copper IUD

Outcomes

Primary Outcomes

User satisfaction of the contraception method with Mirena or Copper IUD

Time Frame: up to 12 months

Secondary Outcomes

Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations)(up to 12 months)
Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUD(up to 12 months)
Relationship between different parameters and women preferences in choosing Mirena or Cooper IUD as their contraceptive method ( demographic parameters, age group, residence, reproductive history and plans, etc.) using patients questionnaire(up to 12 months)
Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies)(up to 12 months)