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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01198444
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : November 2, 2011
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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) Phase 4

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 : December 2007
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Group/Cohort 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.

Primary Outcome Measures :
  1. The percentage of users showing noncompliant behaviors [ Time Frame: 3 consecutive cycles ]

Secondary Outcome Measures :
  1. The characteristics of noncompliant behavior [ Time Frame: 3 consecutive cycles ]
  2. The relation between noncompliant behavior and selected factors [ Time Frame: 3 consecutive cycles ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Gynecological practices patients - starters or current users.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01198444

Many Locations, Poland
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Medical Director, Bayer Sp. z o.o. Identifier: NCT01198444     History of Changes
Other Study ID Numbers: 14340
YA0712PL ( Other Identifier: Company Internal )
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: November 2011

Keywords provided by Bayer:

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female