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To Evaluate Compliance to Treatment Regimen (Rate of Deviations From the Prescribed Regimen) in Polish Females Treated With Different Low Dose Oral Contraceptives

NCT ID: NCT01198444

Last Updated: 2011-11-02

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

11884 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-05-31

Brief Summary

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Adherence to the dosing scheme is the principal element of Combined Oral Contraceptives efficiency. On the other hand noncompliance seemed to be an inseparable element of any oral treatment. The aim of the study is to evaluate in everyday practice the relation between dosage errors and indicated factors, potentially influencing the compliance with the dosing scheme.

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

EE/DRSP (Yasmin Product Family)

Intervention Type DRUG

One tablet per day, orally, 21 tablets followed by 7 days, during three consecutive cycles.

Interventions

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EE/DRSP (Yasmin Product Family)

One tablet per day, orally, 21 tablets followed by 7 days, during three consecutive cycles.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients at the age of over 18 requiring contraception. The decisions would be made at the discretion of the attending physician.

Exclusion Criteria

* According to official Summary of Product Characteristics (SmPC) contraindications.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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 Sp. z o.o.

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Poland

Site Status

Countries

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Poland

Other Identifiers

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YA0712PL

Identifier Type: OTHER

Identifier Source: secondary_id

14340

Identifier Type: -

Identifier Source: org_study_id