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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01198444
• Collaborator: (none)
• Enrollment: 11,884
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 2379.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: EE/DRSP (Yasmin Product Family)

Study Design

• Study Type: Observational
• Actual Enrollment: 11884 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Group 1	Drug: EE/DRSP (Yasmin Product Family); One tablet per day, orally, 21 tablets followed by 7 days, during three consecutive cycles.

Outcome Measures

Primary Outcome Measures

1. The percentage of users showing noncompliant behaviors [3 consecutive cycles]

Secondary Outcome Measures

1. The characteristics of noncompliant behavior [3 consecutive cycles]

2. The relation between noncompliant behavior and selected factors [3 consecutive cycles]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Poland

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01198444
• Other Study ID Numbers: 14340; YA0712PL
• First Posted: Sep 10, 2010
• Last Update Posted: Nov 2, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by , ,: Contraception; Compliance
• Additional relevant MeSH terms: Drospirenone and ethinyl estradiol combination

Study Results

No Results Posted as of Nov 2, 2011