ContraceptionNCT01602770
Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy
An observational study of Contraception, run by Bayer at 1 site in Mexico.
Trial summary
Qlaira is a combined oral contraceptive (COC) containing dienogest/estradiol valerate being the first oral contraceptive delivering estradiol. It has been recently approved in Mexico. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- EV/DNG (Qlaira, BAY86-5027)
- Type of treatment
- Pill or oral medicine
- How many people
- 1 participants
- Where
- 1 siteMexico
- Study dates
- 6 Feb 2015to 31 Oct 2017
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Cohort of healthy women of reproductive age currently Qlaira users from selected obstetrics and gynecology (Ob/Gyn) primary care clinics
Who may be able to join
- Healthy women of reproductive age who are:
- Seeking fertility control with oral contraception at least for one year
- Able to go back to medical office on regular basis
Who cannot join
- Women with risk parameters of arterial or venous thrombotic diseases such as:
- Smoke, if over age 35
- Deep vein thrombosis or pulmonary embolism, now or in the past
- Cerebrovascular disease
- Coronary artery disease
- Thrombogenic valvular or thrombogenic rhythm diseases of the heart
Show all 14Show fewer
- Inherited or acquired hypercoagulopathies
- Uncontrolled hypertension
- Diabetes with vascular disease
- Headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35
- Undiagnosed abnormal genital bleeding
- Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
- Liver tumors, benign or malignant, or liver disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Non-interventional, 2-year Post-authorization Safety Study for QLAIRA®
Qlaira is a combined oral contraceptive (COC) containing dienogest/estradiol valerate being the first oral contraceptive delivering estradiol. It has been recently approved in Mexico. To evaluate the clinical profile of this drug combination under routine medical condition, a post-authorization safety study required by Mexican Health Authorities will be conducted in Mexican women.
The study will be performed as a descriptive study, no hypothesis will be tested. The cohort consists of 300 new users (first-ever users or switchers) of Qlaira under routine medical conditions. Subjects should provide all necessary information on health-related events or changes in health status during Qlaira use.
Read more
Primary variable will be the incidence of Adverse Events (AE) at any time point, whether or not related to Qlaira during at least 2 years of observation.
In order to comply with the criteria of a non-interventional study, women only will be informed about the study, asked to participate and included in the study after Qlaira has been prescribed.
Study patients follow-up will be done in accordance with common clinical practice as described at Mexican Official Guidelines for prescription of Family Planning Methods (NOM 005-SSA2-1993).
- Conditions
- Contraception
- Being tested
- EV/DNG (Qlaira, BAY86-5027)
- Keywords
- Oral contraceptives, Adverse events, Safety profile, Contraceptive Agents
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
Qlaira is taken daily continously with no pause between cycles in a four-phasic dose regimen, making up a treatment of up to 28 days. The first two tablets contain 3 mg Estradiol Valerate (E2V). The next five tablets include 2 mg E2V and 2 mg Dienogest (DNG) followed by 17 tablets with 2 mg E2V and 3 mg DNG. Finally, there are two tablets with 1 mg E2V and two placebo tablets.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Qlaira is taken daily continously with no pause between cycles in a four-phasic dose regimen, making up a treatment of up to 28 days. The first two tablets contain 3 mg Estradiol Valerate (E2V). The next five tablets include 2 mg E2V and 2 mg Dienogest (DNG) followed by 17 tablets with 2 mg E2V and 3 mg DNG. Finally, there are two tablets with 1 mg E2V and two placebo tablets. Receives: Drug: EV/DNG (Qlaira, BAY86-5027) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables will be summarized using descriptive statistics based on adverse events collection
Measured: After 24 months
Continuation rate, as proportion of patients still using Qlaira
Measured: After 24 months
Secondary outcomes (2)
Reasons for discontinuation related or unrelated to adverse events
Measured: After 24 months
Patient satisfaction with Qlaira
Measured: After 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study start6 Feb 2015
- Primary completion17 May 2017
- Study completion31 Oct 2017
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
- 1 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
- NCT01602770
- Sponsor's protocol ID
- 16233
- Other IDs
- QL1210MX
- Status last verified
- Apr 2019
- First submitted
- 18 May 2012
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-interventional, 2-year Post-authorization Safety Study for QLAIRA®
- ClinicalTrials.gov ID
- NCT01602770
- Acronym / sponsor ID
- 16233
- Conditions
- Contraception
- Keywords
- Oral contraceptives, Adverse events, Safety profile, Contraceptive Agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2015 (actual)
- Primary completion
- 17 May 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 21 May 2012 (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.
Qlaira is a combined oral contraceptive (COC) containing dienogest/estradiol valerate being the first oral contraceptive delivering estradiol. It has been recently approved in Mexico. To evaluate the clinical profile of this drug combination under routine medical condition, a post-authorization safety study required by Mexican Health Authorities will be conducted in Mexican women.
The study will be performed as a descriptive study, no hypothesis will be tested. The cohort consists of 300 new users (first-ever users or switchers) of Qlaira under routine medical conditions. Subjects should provide all necessary information on health-related events or changes in health status during Qlaira use.
Primary variable will be the incidence of Adverse Events (AE) at any time point, whether or not related to Qlaira during at least 2 years of observation.
In order to comply with the criteria of a non-interventional study, women only will be informed about the study, asked to participate and included in the study after Qlaira has been prescribed.
Study patients follow-up will be done in accordance with common clinical practice as described at Mexican Official Guidelines for prescription of Family Planning Methods (NOM 005-SSA2-1993).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: EV/DNG (Qlaira, BAY86-5027)Qlaira is taken daily continously with no pause between cycles in a four-phasic dose regimen, making up a treatment of up to 28 days. The first two tablets contain 3 mg Estradiol Valerate (E2V). The next five tablets include 2 mg E2V and 2 mg Dienogest (DNG) followed by 17 tablets with 2 mg E2V and 3 mg DNG. Finally, there are two tablets with 1 mg E2V and two placebo tablets. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Cohort of healthy women of reproductive age currently Qlaira users from selected obstetrics and gynecology (Ob/Gyn) primary care clinics
Key inclusion criteria (3 listed)
- Seeking fertility control with oral contraception at least for one year
- Able to go back to medical office on regular basis
Key exclusion criteria (14 listed)
- Smoke, if over age 35
- Deep vein thrombosis or pulmonary embolism, now or in the past
- Cerebrovascular disease
- Coronary artery disease
- Thrombogenic valvular or thrombogenic rhythm diseases of the heart
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)Qlaira is taken daily continously with no pause between cycles in a four-phasic dose regimen, making up a treatment of up to 28 days. The first two tablets contain 3 mg Estradiol Valerate (E2V). The next five tablets include 2 mg E2V and 2 mg Dienogest (DNG) followed by 17 tablets with 2 mg E2V and 3 mg DNG. Finally, there are two tablets with 1 mg E2V and two placebo tablets. | Drug | Group 1 |
Primary outcome
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time frame: After 24 months
Continuation rate, as proportion of patients still using Qlaira
Time frame: After 24 months
2 secondary outcomes
Reasons for discontinuation related or unrelated to adverse events
Time frame: After 24 months
Patient satisfaction with Qlaira
Time frame: After 24 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 29 Apr 2019.
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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 Mexico.
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 14 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 29 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 Mexico. 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?
Safety variables will be summarized using descriptive statistics based on adverse events collection (time frame: After 24 months). The study lists 2 primary outcomes in all. 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 29 Apr 2019.