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:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01198444
First received: September 9, 2010
Last updated: October 31, 2011
Last verified: November 2011
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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 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 May 23, 2013