check_circleStudy Completed

Contraception

Bayer Identifier:

14340

ClinicalTrials.gov Identifier:

NCT01198444

EudraCT Number:

Not Available

EU CT Number:

Not Available
To evaluate compliance to treatment regimen (rate of deviations from the prescribed regimen) in Polish females treated with different low dose oral contraceptives

Trial 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.

Key Participants Requirements

Sex

Female

Age

18 - 50 Years
  • - Patients at the age of over 18 requiring contraception. The decisions would be made at the discretion of the attending physician.
  • - According to official Summary of Product Characteristics (SmPC) contraindications.

Trial summary

Enrollment Goal
11884
Trial Dates
December 2007 - May 2008
Phase
Phase 4
Could I Receive a placebo
No
Products
EE/DRSP (Yasmin Product Family)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Poland

Primary Outcome

  • The percentage of users showing noncompliant behaviors
    date_rangeTime Frame:
    3 consecutive cycles
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • The characteristics of noncompliant behavior
    date_rangeTime Frame:
    3 consecutive cycles
    enhanced_encryption
    Safety Issue:
    No
  • The relation between noncompliant behavior and selected factors
    date_rangeTime Frame:
    3 consecutive cycles
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
1

Additional Information

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