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

Contraception Clinical Trial

— DOC  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198444
• Other study ID #: 14340
• Secondary ID: YA0712PL
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2010
• Last updated: October 31, 2011
• Start date: December 2007
• Est. completion date: May 2008

Study information

• Verified date: November 2011
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11884
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• EE/DRSP (Yasmin Product Family)
One tablet per day, orally, 21 tablets followed by 7 days, during three consecutive cycles.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of users showing noncompliant behaviors		3 consecutive cycles	No
Secondary	The characteristics of noncompliant behavior		3 consecutive cycles	No
Secondary	The relation between noncompliant behavior and selected factors		3 consecutive cycles	No

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