Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
Bayer Identifier:
First received: August 19, 2010
Last updated: June 25, 2013
Last verified: June 2013
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
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) ]

Secondary Outcome Measures:
  • The characteristics of noncompliant behavior. [ Time Frame: 3 consecutive cycles (28-days per cycle) ]
  • The relation between noncompliant behavior and selected factors. [ Time Frame: 3 consecutive cycles (28-days per cycle) ]

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.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Gynecological practices ptients - starters or current users.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01185678

Many Locations, Poland
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Director, Bayer Sp. z o.o. Identifier: NCT01185678     History of Changes
Other Study ID Numbers: 15253
WH1011PL ( Other Identifier: Company internal )
Study First Received: August 19, 2010
Last Updated: June 25, 2013

Keywords provided by Bayer:

Additional relevant MeSH terms:
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Female
Reproductive Control Agents
Contraceptives, Oral, Synthetic processed this record on April 28, 2017