ContraceptionNCT01797809
Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea
An observational study of Contraception, run by Bayer at 1 site in South Korea.
Trial summary
The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by KFDA (Korea Food and drug administration) Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Contraception
- What is being tested?
- EV/DNG (Qlaira, BAY86-5027)
- How many people
- 757 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 May 2013to 8 May 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Generally healthy women after menarche and before menopause desiring contraception with or without HMB will be recruited who are determined to start Qlaira
Who may be able to join
- Signed and dated informed consent
- Women after menarche and before menopause
- Women requesting contraception or Women diagnosed by a physician as having HMB due to non-organic cause who are also requesting contraception
- Women who are prescribed Qlaira® for the first time, during the study period
Who cannot join
- All contraindications according to the local marketing authorization have to be considered.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qlaira® Regulatory Post Marketing Surveillance Study in Korea
The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by KFDA (Korea Food and drug administration)
- Conditions
- Contraception
- Being tested
- EV/DNG (Qlaira, BAY86-5027)
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
Patients in daily life clinical practice tratment receiving Qlaira according to indication on the label.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: EV/DNG (Qlaira, BAY86-5027) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) including serious adverse events (SAEs) and Adverse Drug Reactions (ADRs)
Measured: Up to 6 months
Secondary outcomes (4)
Contraceptive Efficacy by Number of unintended pregnancies
Measured: From 3 to 6 months
Contraceptive Efficacy by Compliance with Qlaira taking : Administered tablet number/prescribed tablet number
Measured: From 3 to 6 months
The relief of heavy menstrual bleeding symptom also will be calculated as an efficacy variable from admission to the study until final visit by subject's assessment
Measured: From 3 to 6 months
Number of subjects with improved heavy menstrual bleeding
Measured: From 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study start11 May 2013
- Primary completion16 Jan 2018
- Study completion8 May 2018
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
- 757 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
- NCT01797809
- Sponsor's protocol ID
- 16344
- Other IDs
- QL1212KR
- Status last verified
- Mar 2019
- First submitted
- 21 Feb 2013
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qlaira® Regulatory Post Marketing Surveillance Study in Korea
- ClinicalTrials.gov ID
- NCT01797809
- Acronym / sponsor ID
- 16344
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 757 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 11 May 2013 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 8 May 2018 (actual)
- First posted
- 25 Feb 2013 (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.
The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by KFDA (Korea Food and drug administration)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: EV/DNG (Qlaira, BAY86-5027) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Generally healthy women after menarche and before menopause desiring contraception with or without HMB will be recruited who are determined to start Qlaira
Key inclusion criteria (4 listed)
- Signed and dated informed consent
- Women after menarche and before menopause
- Women requesting contraception or Women diagnosed by a physician as having HMB due to non-organic cause who are also requesting contraception
- Women who are prescribed Qlaira® for the first time, during the study period
Key exclusion criteria (1 listed)
- All contraindications according to the local marketing authorization have to be considered.
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)Patients in daily life clinical practice tratment receiving Qlaira according to indication on the label. | Drug | Group 1 |
Primary outcome
Incidence of adverse events (AEs) including serious adverse events (SAEs) and Adverse Drug Reactions (ADRs)
Time frame: Up to 6 months
4 secondary outcomes
Contraceptive Efficacy by Number of unintended pregnancies
Time frame: From 3 to 6 months
Contraceptive Efficacy by Compliance with Qlaira taking : Administered tablet number/prescribed tablet number
Time frame: From 3 to 6 months
The relief of heavy menstrual bleeding symptom also will be calculated as an efficacy variable from admission to the study until final visit by subject's assessment
Time frame: From 3 to 6 months
Number of subjects with improved heavy menstrual bleeding
Time frame: From 3 to 6 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 9 Apr 2019.
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
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 South Korea.
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 4 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 9 Apr 2019. 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 South Korea. 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?
Incidence of adverse events (AEs) including serious adverse events (SAEs) and Adverse Drug Reactions (ADRs) (time frame: Up to 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 9 Apr 2019.