NCT01198444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,884

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
Last Updated

November 2, 2011

Status Verified

November 1, 2011

Enrollment Period

5 months

First QC Date

September 9, 2010

Last Update Submit

October 31, 2011

Conditions

Contraception

Keywords

ContraceptionCompliance

Outcome Measures

Primary Outcomes (1)

  • The percentage of users showing noncompliant behaviors

    3 consecutive cycles

Secondary Outcomes (2)

  • The characteristics of noncompliant behavior

    3 consecutive cycles

  • The relation between noncompliant behavior and selected factors

    3 consecutive cycles

Study Arms (1)

Group 1

Drug: EE/DRSP (Yasmin Product Family)

Interventions

EE/DRSP (Yasmin Product Family)DRUG

One tablet per day, orally, 21 tablets followed by 7 days, during three consecutive cycles.

Group 1

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Gynecological practices patients - starters or current users.

You may qualify if:

  • Patients at the age of over 18 requiring contraception. The decisions would be made at the discretion of the attending physician.

You may not qualify if:

  • According to official Summary of Product Characteristics (SmPC) contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Poland

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 10, 2010

Study Start

December 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

November 2, 2011

Record last verified: 2011-11

Locations

PL(1)