Many Locations, Poland
NCT Number: NCT01185678
Data on Oral Contraceptives Compliance in Non Stop Regimen
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.
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
Female
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Qlaira or Yaz (BSP products defined as Combined Oral Contraceptive) and Cerazette or Azalia (competitor's products defined as Progestogen Only Pill)
DrugOne tablet per day, orally, 28 tablets per cycle, during three consecutive cycles.
Primary outcomes
-
The percentage of users showing noncompliant behaviors
Time frame: 3 consecutive cycles (28-days per cycle)
Secondary outcomes
-
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)
Sponsors and collaborators
Lead sponsor
Bayer
Industry
Registry information
Official study 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).
Acronym: DOC Non Stop
Important dates
- Study start
- 2010
- Primary completion
- 2010
- Study completion
- 2010
- First posted
- Aug 20, 2010
- Registry last updated
- Jun 27, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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