ContraceptionNCT00905684
Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC)
An observational study of Contraception, run by Bayer at 13 sites in 13 countries.
Trial summary
This study is a prospective, company-sponsored, non-interventional cohort study of up to 5000 patients in European countries and countries in Middle East who are newly prescribed any available OC. Patients will be followed up approximately 6 months after initial visit. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraception
- What is being tested?
- EE30/DRSP (Yasmin, BAY86-5131) and Any other OC
- How many people
- 5,446 participants
- Where
- 13 sitesin 13 countries
- Study dates
- Jun 2009to Dec 2011
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who have been found eligible for OC use and have newly been prescribed an OC in accordance with the terms of the respective marketing authorization Starter (first-ever user of an OC) and switcher from another OC (incl. women with a history of OC use)
Who may be able to join
- Women who have been found eligible for OC use and have newly been prescribed an OC in accordance with the terms of the respective marketing authorization
- Starter (first-ever user of an OC) and switcher from another OC (incl. women with a history of OC use)
Who cannot join
- The contraindications and warnings of the Summary of Product Characteristics must be followed.
Trial locations and contacts
13 sites in 13 countries.
13 sites in 13 countries
About this study
Official title: Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC))
This study is a prospective, company-sponsored, non-interventional cohort study of up to 5000 patients in European countries and countries in Middle East who are newly prescribed any available OC. Patients will be followed up approximately 6 months after initial visit. Selection of Study Population: Women can be enrolled after decision for treatment with Yasmin or any other OC has been made. Physicians should consult the full prescribing information for the respective OC before enrolling patients and familiarize themselves with the safety information in the product package label.
- Conditions
- Contraception
- Being tested
- EE30/DRSP (Yasmin, BAY86-5131), Any other OC
- Keywords
- Compliance, Hormonal Contraception
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EE30/DRSP (Yasmin, BAY86-5131)Drug
Patients under regular daily life treatment receiving Yasmin according to local drug information
Any other OCDrug
Patients under regular daily life treatment receiving any other OC according to local drug information
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: EE30/DRSP (Yasmin, BAY86-5131) | |
| Group 2 | Not described Receives: Drug: Any other OC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyses of continuation rates and compliance stratified by the subject's knowledge on the respective topics and time spent for counseling.
Measured: After 3 months and at end of study after approx. 6 months.
Secondary outcomes (2)
Analyses stratified by baseline factors such as age group, presence or absence of cycle disorders, and history of oral contraceptive method will be performed as well.
Measured: After 3 months and after approx. 6 months.
Special attention will be paid to serious adverse events and unexpected or unlisted ADRs.
Measured: Over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startJun 2009
- Study completionDec 2011
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
- 5,446 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
- NCT00905684
- Sponsor's protocol ID
- 14565
- Other IDs
- YA0801
- Status last verified
- Mar 2012
- First submitted
- 18 May 2009
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC))
- ClinicalTrials.gov ID
- NCT00905684
- Acronym / sponsor ID
- 14565
- Conditions
- Contraception
- Keywords
- Compliance, Hormonal Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,446 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Study completion
- Dec 2011 (actual)
- First posted
- 20 May 2009 (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.
This study is a prospective, company-sponsored, non-interventional cohort study of up to 5000 patients in European countries and countries in Middle East who are newly prescribed any available OC. Patients will be followed up approximately 6 months after initial visit. Selection of Study Population: Women can be enrolled after decision for treatment with Yasmin or any other OC has been made. Physicians should consult the full prescribing information for the respective OC before enrolling patients and familiarize themselves with the safety information in the product package label.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: EE30/DRSP (Yasmin, BAY86-5131) |
| Group 2 | – | Drug: Any other OC |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have been found eligible for OC use and have newly been prescribed an OC in accordance with the terms of the respective marketing authorization Starter (first-ever user of an OC) and switcher from another OC (incl. women with a history of OC use)
Key inclusion criteria (2 listed)
- Women who have been found eligible for OC use and have newly been prescribed an OC in accordance with the terms of the respective marketing authorization
- Starter (first-ever user of an OC) and switcher from another OC (incl. women with a history of OC use)
Key exclusion criteria (1 listed)
- The contraindications and warnings of the Summary of Product Characteristics must be followed.
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 |
|---|---|---|
| EE30/DRSP (Yasmin, BAY86-5131)Patients under regular daily life treatment receiving Yasmin according to local drug information | Drug | Group 1 |
| Any other OCPatients under regular daily life treatment receiving any other OC according to local drug information | Drug | Group 2 |
Primary outcome
Analyses of continuation rates and compliance stratified by the subject's knowledge on the respective topics and time spent for counseling.
Time frame: After 3 months and at end of study after approx. 6 months.
2 secondary outcomes
Analyses stratified by baseline factors such as age group, presence or absence of cycle disorders, and history of oral contraceptive method will be performed as well.
Time frame: After 3 months and after approx. 6 months.
Special attention will be paid to serious adverse events and unexpected or unlisted ADRs.
Time frame: Over 12 months
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 7 Mar 2012.
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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
13 sites in 13 countries: 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 13 sites in 13 countries.
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 2 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 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Albania, Bahrain, Egypt, Hungary, Jordan and 8 more countries. 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?
Analyses of continuation rates and compliance stratified by the subject's knowledge on the respective topics and time spent for counseling. (time frame: After 3 months and at end of study after approx. 6 months.). 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 7 Mar 2012.