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

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.

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Key information

Conditions

Contraception Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EE/DRSP (Yasmin Product Family)

Drug

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

Primary outcomes

The percentage of users showing noncompliant behaviors

Time frame: 3 consecutive cycles

Secondary outcomes

The characteristics of noncompliant behavior

Time frame: 3 consecutive cycles
The relation between noncompliant behavior and selected factors

Time frame: 3 consecutive cycles

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Prospective, Open-label Observational Survey Evaluating Patients Compliance to Administration Regimen During Low Dose Combined Oral Contraceptive Use in Everyday Praxis Data on Oral Contraceptives Compliance - DOC Study

Acronym: DOC

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Sep 10, 2010
Registry last updated: Nov 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed