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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

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

Phase: N/A

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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).

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: User satisfaction of the contraception method with Mirena or Copper IUD

Secondary outcome:

Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUD

Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies)

Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations)

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


Minimum age: 20 Years. Maximum age: 40 Years. Gender(s): Female.


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

Locations and Contacts

Many Locations, Russian Federation
Additional Information

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Starting date: September 2011
Last updated: November 10, 2014

Page last updated: August 23, 2015

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