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

Observation of Compliance With Dosage in Women Using Oral Contraceptives Designed for the Non Stop Use, (it Means 28 Pills for 28-days Cycle).

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: 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
• Enrollment (Actual): 8416

Contacts and Locations

Study Locations

• Poland
  • Many Locations, Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Gynecological practices ptients - starters or current users.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage of users showing noncompliant behaviors	3 consecutive cycles (28-days per cycle)

Secondary Outcome Measures

Outcome Measure	Time Frame
The characteristics of noncompliant behavior.	3 consecutive cycles (28-days per cycle)
The relation between noncompliant behavior and selected factors.	3 consecutive cycles (28-days per cycle)

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: August 19, 2010
• First Submitted That Met QC Criteria: August 19, 2010
• First Posted (Estimate): August 20, 2010

Study Record Updates

• Last Update Posted (Estimate): June 27, 2013
• Last Update Submitted That Met QC Criteria: June 25, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Contraception; Compliance
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Contraceptive Agents, Hormonal; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Progestins; Desogestrel
• Other Study ID Numbers: 15253; WH1011PL (Other Identifier: Company internal)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No