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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01198444
First received: September 9, 2010
Last updated: October 31, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Contraception
Drug: EE/DRSP (Yasmin Product Family)
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • The percentage of users showing noncompliant behaviors [ Time Frame: 3 consecutive cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The characteristics of noncompliant behavior [ Time Frame: 3 consecutive cycles ] [ Designated as safety issue: No ]
  • The relation between noncompliant behavior and selected factors [ Time Frame: 3 consecutive cycles ] [ Designated as safety issue: No ]

Enrollment: 11884
Study Start Date: December 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: EE/DRSP (Yasmin Product Family)
One tablet per day, orally, 21 tablets followed by 7 days, during three consecutive cycles.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Gynecological practices patients - starters or current users.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198444

Locations
Poland
Many Locations, Poland
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Director, Bayer Sp. z o.o.
ClinicalTrials.gov Identifier: NCT01198444     History of Changes
Other Study ID Numbers: 14340, YA0712PL
Study First Received: September 9, 2010
Last Updated: October 31, 2011
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Bayer:
Contraception
Compliance

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 16, 2014