Data on Oral Contraceptives Compliance in Non Stop Regimen (DOC Non Stop)
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01185678
First received: August 19, 2010
Last updated: February 6, 2012
Last verified: February 2012
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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.
| Condition | Intervention |
|---|---|
|
Contraception |
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:
MedlinePlus related topics:
Birth Control
Drug Information available for:
Desogestrel
U.S. FDA Resources
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) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The characteristics of noncompliant behavior. [ Time Frame: 3 consecutive cycles (28-days per cycle) ] [ Designated as safety issue: No ]
- The relation between noncompliant behavior and selected factors. [ Time Frame: 3 consecutive cycles (28-days per cycle) ] [ Designated as safety issue: No ]
| Enrollment: | 11397 |
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Gynecological practices ptients - starters or current users.
Criteria
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Director, Bayer Sp. z o.o. |
| ClinicalTrials.gov Identifier: | NCT01185678 History of Changes |
| Other Study ID Numbers: | 15253, WH1011PL |
| Study First Received: | August 19, 2010 |
| Last Updated: | February 6, 2012 |
| Health Authority: | Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Keywords provided by Bayer:
|
Contraception Compliance |
Additional relevant MeSH terms:
|
Contraceptive Agents Desogestrel Contraceptives, Oral Contraceptives, Oral, Combined Progestins Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptives, Oral, Synthetic |
ClinicalTrials.gov processed this record on May 19, 2013