Data on Oral Contraceptives Compliance in Non Stop Regimen

Contraception Clinical Trial

— DOC Non Stop  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185678
• Other study ID #: 15253
• Secondary ID: WH1011PL
• Status: Completed
• Phase: N/A
• First received: August 19, 2010
• Last updated: June 25, 2013
• Start date: May 2010
• Est. completion date: November 2010

Study information

• Verified date: June 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8416
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of users showing noncompliant behaviors		3 consecutive cycles (28-days per cycle)	No
Secondary	The characteristics of noncompliant behavior.		3 consecutive cycles (28-days per cycle)	No
Secondary	The relation between noncompliant behavior and selected factors.		3 consecutive cycles (28-days per cycle)	No

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