Data on Oral Contraceptives Compliance in Non Stop Regimen (DOC Non Stop)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01185678
First received: August 19, 2010
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

Adherence to the dosing scheme is the principal element of COC 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
Contraception
Drug: Qlaira or Yaz (BSP products defined as Combined Oral Contraceptive) and Cerazette or Azalia (competitor's products defined as Progestogen Only Pill)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observation of Compliance With Dosage in Women Using Oral Contraceptives Designed for the Non Stop Use, (it Means 28 Pills for 28-days Cycle).

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 (28-days per cycle) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The characteristics of noncompliant behavior. [ Time Frame: 3 consecutive cycles (28-days per cycle) ] [ Designated as safety issue: No ]
  • The relation between noncompliant behavior and selected factors. [ Time Frame: 3 consecutive cycles (28-days per cycle) ] [ Designated as safety issue: No ]

Enrollment: 8416
Study Start Date: May 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group1 Drug: Qlaira or Yaz (BSP products defined as Combined Oral Contraceptive) and Cerazette or Azalia (competitor's products defined as Progestogen Only Pill)
One tablet per day, orally, 28 tablets per cycle, 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 ptients - starters or current users.

Criteria

Inclusion Criteria:

  • Patients at the age of 18-50 requiring contraception, treated with oral contraceptives designed for the scheme 28 pills for 28 days. The decisions would be made at the discretion of the attending physician.

Exclusion Criteria:

  • Patients were not valid for analysis if the initial visit was before start of study in the country (retrospective documentation), or if they did not take oral contraceptives designed for the scheme 28 pills for 28 days.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01185678

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: NCT01185678     History of Changes
Other Study ID Numbers: 15253, WH1011PL
Study First Received: August 19, 2010
Last Updated: June 25, 2013
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 18, 2014