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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01590537
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : October 16, 2015
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment
Contraception Drug: Levonorgestrel (Mirena, BAY86-5028) Device: Copper IUD

Study Type : Observational
Actual Enrollment : 2348 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Multicentre Non-interventional Comparative Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction
Study Start Date : September 2011
Primary Completion Date : March 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1 Drug: Levonorgestrel (Mirena, BAY86-5028)
intrauterine system containing 52 mg levonorgestrel, with daily release of 20 mcg levonorgestrel
Group 2 Device: Copper IUD
Copper device, inserted intrauterine

Primary Outcome Measures :
  1. User satisfaction of the contraception method with Mirena or Copper IUD [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Females who plan long-term contraception and meet criteria of inclusion and exclusion.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01590537

Russian Federation
Many Locations, Russian Federation
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT01590537     History of Changes
Other Study ID Numbers: 15508
MA1010RU ( Other Identifier: company internal )
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by Bayer:
Russian Federation

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Growth Substances