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

Completed

• Conditions: Contraception
• Interventions: Drug: Levonorgestrel (Mirena, BAY86-5028); Device: Copper IUD

• Registration Number: NCT01590537
• Lead Sponsor: Bayer

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-05-02
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-03
• Primary Completion: 2014-03
• Study Completion: 2014-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-15
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2348

Inclusion Criteria

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

Read More

Exclusion Criteria

• in accordance with the current leaflet

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Levonorgestrel (Mirena, BAY86-5028)	-
Group 2	Copper IUD	-

Primary Outcome Measures

Name	Time	Method
User satisfaction of the contraception method with Mirena or Copper IUD	up to 12 months

Secondary Outcome Measures

Name	Time	Method
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