Contraceptives, OralNCT01200186
Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction
An observational study of Contraceptives, Oral, run by Bayer at 11 sites in 11 countries.
Trial summary
Prospective, non-interventional, multi-center study. Each subject will be followed for up to twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin Only Pill). For each subject demographic data and medical history will be documented at Visit 1: (Baseline). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Contraceptives, Oral
- What is being tested?
- EV/DNG (Qlaira, BAY86-5027) and Progestin Only Pills
- Type of treatment
- Pill or oral medicine
- How many people
- 3,258 participants
- Where
- 11 sitesin 11 countries
- Study dates
- Oct 2010to Oct 2014
- 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: Women in gynecological practice
Who may be able to join
- Women between 18-50 years
- Women who used ethinylestradiol containing oral contraceptives for at least the three preceding months before the study
- Women who decided to start Qlaira® or a Progestin Only Pill. The prescription of the hormonal contraceptive is made at the discretion of the attending physician and has to be documented
Who cannot join
- Contraindications and warnings of the respective Summary of Product Characteristics (Qlaira® or Progestin Only Pill)
- Women who are breast-feeding
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
About this study
Prospective, non-interventional, multi-center study. Each subject will be followed for up to twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin Only Pill). For each subject demographic data and medical history will be documented at Visit 1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2 (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.
- Conditions
- Contraceptives, Oral
- Being tested
- EV/DNG (Qlaira, BAY86-5027), Progestin Only Pills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV/DNG (Qlaira, BAY86-5027)Drug
At the discretion of the attending physician
Progestin Only PillsDrug
At the discretion of the attending physician
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: EV/DNG (Qlaira, BAY86-5027) | |
| Group 2 | Not described Receives: Drug: Progestin Only Pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities.
Measured: up to 12 Months
Secondary outcomes (13)
Time to event for discontinuation due to reasons other than bleeding irregularities
Measured: Month 3-5
Time to event for discontinuation due to reasons other than bleeding irregularities
Measured: Month 6-12
Number of intracyclic bleeding
Measured: Month 3-5
Number of intracyclic bleeding
Measured: Month 6-12
Number of heavy and/or prolonged bleeding
Measured: Month 3-5
Number of heavy and/or prolonged bleeding
Measured: Month 6-12
Number of unintended pregnancies
Measured: Month 3-5
Number of unintended pregnancies
Measured: Month 6-12
Discontinuation rate for the following reasons: Occasional absent or persistent absent withdrawal bleeding , intracyclic bleeding, heavy and/or prolonged bleeding, other medical reasons, non-medical reasons
Measured: Month 3-5
Discontinuation rate for the following reasons: Occasional absent or persistent absent withdrawal bleeding , intracyclic bleeding, heavy and/or prolonged bleeding, other medical reasons, non-medical reasons
Measured: Month 6-12
Global assessment of well-being and satisfaction
Measured: Month 3-5
Global assessment of well-being and satisfaction
Measured: Month 6-12
Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapy
Measured: up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptives, OralStudies 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
- 3,258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200186
- Sponsor's protocol ID
- 15217
- Other IDs
- QL0901
- Status last verified
- Oct 2015
- First submitted
- 13 Aug 2010
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction
- ClinicalTrials.gov ID
- NCT01200186
- Acronym / sponsor ID
- 15217
- Conditions
- Contraceptives, Oral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,258 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 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.
Prospective, non-interventional, multi-center study. Each subject will be followed for up to twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin Only Pill). For each subject demographic data and medical history will be documented at Visit 1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2 (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: EV/DNG (Qlaira, BAY86-5027) |
| Group 2 | – | Drug: Progestin Only Pills |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women in gynecological practice
Key inclusion criteria (3 listed)
- Women between 18-50 years
- Women who used ethinylestradiol containing oral contraceptives for at least the three preceding months before the study
- Women who decided to start Qlaira® or a Progestin Only Pill. The prescription of the hormonal contraceptive is made at the discretion of the attending physician and has to be documented
Key exclusion criteria (2 listed)
- Contraindications and warnings of the respective Summary of Product Characteristics (Qlaira® or Progestin Only Pill)
- Women who are breast-feeding
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 |
|---|---|---|
| EV/DNG (Qlaira, BAY86-5027)At the discretion of the attending physician | Drug | Group 1 |
| Progestin Only PillsAt the discretion of the attending physician | Drug | Group 2 |
Primary outcome
The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities.
Time frame: up to 12 Months
13 secondary outcomes
Time to event for discontinuation due to reasons other than bleeding irregularities
Time frame: Month 3-5
Time to event for discontinuation due to reasons other than bleeding irregularities
Time frame: Month 6-12
Number of intracyclic bleeding
Time frame: Month 3-5
Number of intracyclic bleeding
Time frame: Month 6-12
Number of heavy and/or prolonged bleeding
Time frame: Month 3-5
Number of heavy and/or prolonged bleeding
Time frame: Month 6-12
Number of unintended pregnancies
Time frame: Month 3-5
Number of unintended pregnancies
Time frame: Month 6-12
Discontinuation rate for the following reasons: Occasional absent or persistent absent withdrawal bleeding , intracyclic bleeding, heavy and/or prolonged bleeding, other medical reasons, non-medical reasons
Time frame: Month 3-5
Discontinuation rate for the following reasons: Occasional absent or persistent absent withdrawal bleeding , intracyclic bleeding, heavy and/or prolonged bleeding, other medical reasons, non-medical reasons
Time frame: Month 6-12
Global assessment of well-being and satisfaction
Time frame: Month 3-5
Global assessment of well-being and satisfaction
Time frame: Month 6-12
Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapy
Time frame: up to 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 16 Oct 2015.
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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
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraceptives, Oral, run by Bayer at 11 sites in 11 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 3 inclusion and 2 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 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Czechia, France, Germany, Greece, Hungary and 6 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?
The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities. (time frame: up to 12 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 16 Oct 2015.