CClinicalTrials.gg
CompletedNCT01198444DOCUpdated Nov 2, 2011

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

An observational study in Contraception, sponsored by Bayer. Completed at 1 site in Poland. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2011-11-02.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
11,884
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Contraception

Keywords

  • Contraception
  • Compliance
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 56 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 130 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

Exclusion Criteria:

  • According to official Summary of Product Characteristics (SmPC) contraindications.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
11,884 participants (actual)

Groups and cohorts

  • Group 1

    Drug: EE/DRSP (Yasmin Product Family)

Interventions

  • DrugEE/DRSP (Yasmin Product Family)

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

06

What researchers measure

Primary outcomes

  1. The percentage of users showing noncompliant behaviors

    Time frame: 3 consecutive cycles

Secondary outcomes

  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

07

Study locations

1 site
  • Many Locations, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01198444
Lead sponsor
Bayer
First posted
Sep 10, 2010
Start date
Dec 2007
Primary completion
May 2008
Completion
May 2008
Last update
Nov 2, 2011

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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