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

NCT ID: NCT01590537

Last Updated: 2015-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2348 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Contraception

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Levonorgestrel (Mirena, BAY86-5028)

Intervention Type DRUG

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

Group 2

Copper IUD

Intervention Type DEVICE

Copper device, inserted intrauterine

Interventions

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Levonorgestrel (Mirena, BAY86-5028)

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

Intervention Type DRUG

Copper IUD

Copper device, inserted intrauterine

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Russia

Site Status

Countries

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Russia

Other Identifiers

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MA1010RU

Identifier Type: OTHER

Identifier Source: secondary_id

15508

Identifier Type: -

Identifier Source: org_study_id

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