ContraceptionDOCNCT01198444
To Evaluate Compliance to Treatment Regimen (Rate of Deviations From the Prescribed Regimen) in Polish Females Treated With Different Low Dose Oral Contraceptives
An observational study of Contraception, run by Bayer at 1 site in Poland.
Trial summary
Adherence to the dosing scheme is the principal element of Combined Oral Contraceptives efficiency. On the other hand noncompliance seemed to be an inseparable element of any oral treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- EE/DRSP (Yasmin Product Family)
- Type of treatment
- Pill or oral medicine
- How many people
- 11,884 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2007to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Gynecological practices patients - starters or current users.
Who may be able to join
- Patients at the age of over 18 requiring contraception. The decisions would be made at the discretion of the attending physician.
Who cannot join
- According to official Summary of Product Characteristics (SmPC) contraindications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Open-label Observational Survey Evaluating Patients Compliance to Administration Regimen During Low Dose Combined Oral Contraceptive Use in Everyday Praxis Data on Oral Contraceptives Compliance - DOC Study
Adherence to the dosing scheme is the principal element of Combined Oral Contraceptives 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.
- Conditions
- Contraception
- Being tested
- EE/DRSP (Yasmin Product Family)
- Keywords
- Contraception, Compliance
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EE/DRSP (Yasmin Product Family)Drug
One tablet per day, orally, 21 tablets followed by 7 days, during three consecutive cycles.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: EE/DRSP (Yasmin Product Family) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of users showing noncompliant behaviors
Measured: 3 consecutive cycles
Secondary outcomes (2)
The characteristics of noncompliant behavior
Measured: 3 consecutive cycles
The relation between noncompliant behavior and selected factors
Measured: 3 consecutive cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startDec 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,884 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198444
- Sponsor's protocol ID
- 14340
- Other IDs
- YA0712PL
- Acronym
- DOC
- Status last verified
- Nov 2011
- First submitted
- 9 Sep 2010
- Last updated
- 2 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-label Observational Survey Evaluating Patients Compliance to Administration Regimen During Low Dose Combined Oral Contraceptive Use in Everyday Praxis Data on Oral Contraceptives Compliance - DOC Study
- ClinicalTrials.gov ID
- NCT01198444
- Acronym / sponsor ID
- DOC / 14340
- Conditions
- Contraception
- Keywords
- Contraception, Compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,884 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adherence to the dosing scheme is the principal element of Combined Oral Contraceptives 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: EE/DRSP (Yasmin Product Family) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Gynecological practices patients - starters or current users.
Key inclusion criteria (1 listed)
- Patients at the age of over 18 requiring contraception. The decisions would be made at the discretion of the attending physician.
Key exclusion criteria (1 listed)
- According to official Summary of Product Characteristics (SmPC) contraindications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EE/DRSP (Yasmin Product Family)One tablet per day, orally, 21 tablets followed by 7 days, during three consecutive cycles. | Drug | Group 1 |
Primary outcome
The percentage of users showing noncompliant behaviors
Time frame: 3 consecutive cycles
2 secondary outcomes
The characteristics of noncompliant behavior
Time frame: 3 consecutive cycles
The relation between noncompliant behavior and selected factors
Time frame: 3 consecutive cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Bayer at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of users showing noncompliant behaviors (time frame: 3 consecutive cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2011.