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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01198444

Acronym

DOC

Enrollment

11884

Registered

2010-09-10

Start date

2007-12-31

Completion date

2008-05-31

Last updated

2011-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Contraception, Compliance

Brief summary

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.

Interventions

DRUGEE/DRSP (Yasmin Product Family)

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The percentage of users showing noncompliant behaviors	3 consecutive cycles

Secondary

Measure	Time frame
The characteristics of noncompliant behavior	3 consecutive cycles
The relation between noncompliant behavior and selected factors	3 consecutive cycles

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026