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Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC)

NCT ID: NCT00905684

Last Updated: 2012-03-07

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

5446 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-12-31

Brief Summary

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This study is a prospective, company-sponsored, non-interventional cohort study of up to 5000 patients in European countries and countries in Middle East who are newly prescribed any available OC. Patients will be followed up approximately 6 months after initial visit. Selection of Study Population: Women can be enrolled after decision for treatment with Yasmin or any other OC has been made. Physicians should consult the full prescribing information for the respective OC before enrolling patients and familiarize themselves with the safety information in the product package label.

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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

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

EE30/DRSP (Yasmin, BAY86-5131)

Intervention Type DRUG

Patients under regular daily life treatment receiving Yasmin according to local drug information

Group 2

Any other OC

Intervention Type DRUG

Patients under regular daily life treatment receiving any other OC according to local drug information

Interventions

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EE30/DRSP (Yasmin, BAY86-5131)

Patients under regular daily life treatment receiving Yasmin according to local drug information

Intervention Type DRUG

Any other OC

Patients under regular daily life treatment receiving any other OC according to local drug information

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women who have been found eligible for OC use and have newly been prescribed an OC in accordance with the terms of the respective marketing authorization
* Starter (first-ever user of an OC) and switcher from another OC (incl. women with a history of OC use)

Exclusion Criteria

* The contraindications and warnings of the Summary of Product Characteristics must be followed.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer HealthCare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Albania

Site Status

Many Locations, , Bahrain

Site Status

Many Locations, , Egypt

Site Status

Many Locations, , Hungary

Site Status

Many Locations, , Jordan

Site Status

Many Locations, , Kenya

Site Status

Many Locations, , Kuwait

Site Status

Many Locations, , Lebanon

Site Status

Many Locations, , North Macedonia

Site Status

Many Locations, , Oman

Site Status

Many Locations, , Qatar

Site Status

Many Locations, , Saudi Arabia

Site Status

Many Locations, , United Arab Emirates

Site Status

Countries

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Albania Bahrain Egypt Hungary Jordan Kenya Kuwait Lebanon North Macedonia Oman Qatar Saudi Arabia United Arab Emirates

Other Identifiers

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YA0801

Identifier Type: OTHER

Identifier Source: secondary_id

14565

Identifier Type: -

Identifier Source: org_study_id

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