Data on Oral Contraceptives Compliance in Non Stop Regimen

NCT ID: NCT01185678

Last Updated: 2013-06-27

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

8416 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-11-30

Brief Summary

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Adherence to the dosing scheme is the principal element of COC 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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Group1

Qlaira or Yaz (BSP products defined as Combined Oral Contraceptive) and Cerazette or Azalia (competitor's products defined as Progestogen Only Pill)

Intervention Type DRUG

One tablet per day, orally, 28 tablets per cycle, during three consecutive cycles.

Interventions

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Qlaira or Yaz (BSP products defined as Combined Oral Contraceptive) and Cerazette or Azalia (competitor's products defined as Progestogen Only Pill)

One tablet per day, orally, 28 tablets per cycle, during three consecutive cycles.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients at the age of 18-50 requiring contraception, treated with oral contraceptives designed for the scheme 28 pills for 28 days. The decisions would be made at the discretion of the attending physician.

Exclusion Criteria

* Patients were not valid for analysis if the initial visit was before start of study in the country (retrospective documentation), or if they did not take oral contraceptives designed for the scheme 28 pills for 28 days.
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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WH1011PL

Identifier Type: OTHER

Identifier Source: secondary_id

15253

Identifier Type: -

Identifier Source: org_study_id

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