check_circleStudy Completed

Contraception

Bayer Identifier:

15253

ClinicalTrials.gov Identifier:

NCT01185678

EudraCT Number:

Not Available

EU CT Number:

Not Available
Data on Oral Contraceptives Compliance in Non Stop Regimen

Trial 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.

Key Participants Requirements

Sex

Female

Age

18 - 50 Years
  • - 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.

  • - 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.

Trial summary

Enrollment Goal
8416
Trial Dates
May 2010 - November 2010
Phase
N/A
Could I Receive a placebo
No
Products
Drospirenone (DRSP, BAY86-5131)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Poland

Primary Outcome

  • The percentage of users showing noncompliant behaviors
    date_rangeTime Frame:
    3 consecutive cycles (28-days per cycle)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • The characteristics of noncompliant behavior.
    date_rangeTime Frame:
    3 consecutive cycles (28-days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The relation between noncompliant behavior and selected factors.
    date_rangeTime Frame:
    3 consecutive cycles (28-days per cycle)
    enhanced_encryption
    Safety Issue:
    No

Trial design

Observation of compliance with dosage in women using oral contraceptives designed for the non stop use, (it means 28 pills for 28-days cycle).
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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