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Completed

NCT Number: NCT01590537

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

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).

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Key information

Conditions

Contraception

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levonorgestrel (Mirena, BAY86-5028)

Drug

intrauterine system containing 52 mg levonorgestrel, with daily release of 20 mcg levonorgestrel

Copper IUD

Device

Copper device, inserted intrauterine

Primary outcomes

  1. User satisfaction of the contraception method with Mirena or Copper IUD

    Time frame: up to 12 months

Secondary outcomes

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

    Time frame: up to 12 months

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

    Time frame: up to 12 months

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

    Time frame: up to 12 months

  4. 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

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: Mirabel

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 3, 2012
Registry last updated
Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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