Endometriosis and DysmenorrheaNCT03126747
Drug Use Investigation (DUI) of YazFlex for Endometriosis-associated Pelvic Pain and/or Dysmenorrhea
An observational study of Endometriosis and Dysmenorrhea, run by Bayer at 1 site in Japan.
Trial summary
This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometriosis and Dysmenorrhea
- What is being tested?
- BAY86-5300_YAZ-Flex
- How many people
- 715 participants
- Where
- 1 siteJapan
- Study dates
- 29 Jun 2017to 17 Nov 2021
- 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: Endometriosis-associated pelvic pain and/or Dysmenorrhea
Who may be able to join
- Patients with endometriosis-associated pelvic pain and/or dysmenorrhea.
- Patients for whom the decision to initiate treatment with YazFlex is made as per physician's clinical practice.
Who cannot join
- Patients participating in an investigational program with interventions outside of routine clinical practice.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.
Read the detailed description
It is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with YazFlex in endometriosis or dysmenorrhea indication.
A total of 600 patients (300 for endometriosis and 300 for dysmenorrhea) is planned to be enrolled in 2 years.
The treatment should be performed in Japan based on the product label. The patients will be observed for up to 2 years (1 year at the earliest) during their YazFlex treatment.
The outcome variables for the primary objective are treatment emergent adverse events (TEAEs) and adverse drug reactions (ADRs). The outcome variables for the secondary objective include newly developed haemorrhagic ovarian cyst, genital bleeding, severity of dysmenorrhea, pelvic pain and compliance status in the new flexible regimen.
- Conditions
- Endometriosis and Dysmenorrhea
- Being tested
- BAY86-5300_YAZ-Flex
- Medical subject headings
- Endometriosis, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY86-5300_YAZ-FlexDrug
Patients with endometriosis-associated pelvic pain and/or dysmenorrhea are enrolled solely after the physician's decision of YazFlex treatment in routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| BAY86-5300_YAZ-Flex | Patients with endometriosis-associated pelvic pain or dysmenorrhea Receives: Drug: BAY86-5300_YAZ-Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse drug reactions (ADRs)
Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA cording system.
Measured: Up to 2 years ( 1 year at the earliest)
Secondary outcomes (8)
Incidence proportions of YAZ-Flex therapy
Measured: Up to 2 years ( 1 year at the earliest)
Incidence proportions of extent of bleeding
Measured: Up to 2 years ( 1 year at the earliest)
Incidence proportions of treatment suspension
The duration of suspension is defined as a period of at least 3 consecutive days of treatment suspension.
Measured: Up to 2 years ( 1 year at the earliest)
Number of days with menstrual pain
Menstrual pain is continuous menstrual pain or lower abdominal pain that is observed for menstruation or withdrawal blood events and may spread to the back or thigh. Pain may be recognized 2 days before bleeding, and ends by the last day of menstruation or withdrawal.
Measured: Up to 2 years ( 1 year at the earliest)
Number of date of using analgesic
Record the date of using the analgesic.
Measured: Up to 2 years ( 1 year at the earliest)
Change in severity of dysmenorrhea
The severity will be evaluated and recorded the following criteria.
- None
- Somewhat obstructing work (school or housework)
- get a problem with one's work (studies / housework) because the more one wants to lie down
- Fall asleep for more than 1 day, and cannot do one's work (school or housework)
Measured: Up to 2 years ( 1 year at the earliest)
Change in severity of pelvic pain by using Numeric Rating Scale (NRS)
The degree of pelvic pain in each menstrual period, menstrual period, sexual intercourse and defecation will be evaluated using NRS score (11 levels from no pain is "0" to highest pain "10" ) in each month.
Measured: Up to 2 years ( 1 year at the earliest)
Change in quality of Life by using EQ-5D-5L , EIS and/or MDQ
Endometriosis Impact Scale (EIS) (for disease burden of endometriosis) Menstrual Distress Questionnaire (MDQ) (for disease burden of dysmenorrhea) EQ-5D (for general QOL measurement)
Measured: Up to 2 years ( 1 year at the earliest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start29 Jun 2017
- Primary completion17 Jun 2021
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometriosis and DysmenorrheaStudies 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
- 715 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
- NCT03126747
- Sponsor's protocol ID
- 18703
- Status last verified
- Nov 2022
- First submitted
- 20 Apr 2017
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Yoshino O, Suzukamo Y, Yoshihara K, Takahashi N. Quality of Life in Japanese Patients with Dysmenorrhea or Endometriosis-Associated Pelvic Pain Treated with Extended Regimen Ethinylestradiol/Drospirenone in a Real-World Setting: A Prospective Observational Study. Adv Ther. 2022 Nov;39(11):5087-5104. doi: 10.1007/s12325-022-02301-3. Epub 2022 Sep 2.
PubMed 36053449
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation (DUI) of YazFlex for Endometriosis-associated Pelvic Pain and/or Dysmenorrhea
- ClinicalTrials.gov ID
- NCT03126747
- Acronym / sponsor ID
- 18703
- Conditions
- Endometriosis and Dysmenorrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 715 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 24 Apr 2017 (actual)
- 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 Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.
Detailed description
It is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with YazFlex in endometriosis or dysmenorrhea indication.
A total of 600 patients (300 for endometriosis and 300 for dysmenorrhea) is planned to be enrolled in 2 years.
The treatment should be performed in Japan based on the product label. The patients will be observed for up to 2 years (1 year at the earliest) during their YazFlex treatment.
The outcome variables for the primary objective are treatment emergent adverse events (TEAEs) and adverse drug reactions (ADRs). The outcome variables for the secondary objective include newly developed haemorrhagic ovarian cyst, genital bleeding, severity of dysmenorrhea, pelvic pain and compliance status in the new flexible regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAY86-5300_YAZ-Flex | – | Drug: BAY86-5300_YAZ-FlexPatients with endometriosis-associated pelvic pain or dysmenorrhea |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Endometriosis-associated pelvic pain and/or Dysmenorrhea
Key inclusion criteria (2 listed)
- Patients with endometriosis-associated pelvic pain and/or dysmenorrhea.
- Patients for whom the decision to initiate treatment with YazFlex is made as per physician's clinical practice.
Key exclusion criteria (1 listed)
- Patients participating in an investigational program with interventions outside of routine clinical practice.
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 |
|---|---|---|
| BAY86-5300_YAZ-FlexPatients with endometriosis-associated pelvic pain and/or dysmenorrhea are enrolled solely after the physician's decision of YazFlex treatment in routine clinical practice. | Drug | BAY86-5300_YAZ-Flex |
Primary outcome
Number of adverse drug reactions (ADRs)
Time frame: Up to 2 years ( 1 year at the earliest)
Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA cording system.
8 secondary outcomes
Incidence proportions of YAZ-Flex therapy
Time frame: Up to 2 years ( 1 year at the earliest)
Incidence proportions of extent of bleeding
Time frame: Up to 2 years ( 1 year at the earliest)
Incidence proportions of treatment suspension
Time frame: Up to 2 years ( 1 year at the earliest)
Number of days with menstrual pain
Time frame: Up to 2 years ( 1 year at the earliest)
Number of date of using analgesic
Time frame: Up to 2 years ( 1 year at the earliest)
Change in severity of dysmenorrhea
Time frame: Up to 2 years ( 1 year at the earliest)
Change in severity of pelvic pain by using Numeric Rating Scale (NRS)
Time frame: Up to 2 years ( 1 year at the earliest)
Change in quality of Life by using EQ-5D-5L , EIS and/or MDQ
Time frame: Up to 2 years ( 1 year at the earliest)
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 Nov 2022.
- Derived from this study: PubMed 36053449Yoshino O, Suzukamo Y, Yoshihara K, Takahashi N. Quality of Life in Japanese Patients with Dysmenorrhea or Endometriosis-Associated Pelvic Pain Treated with Extended Regimen Ethinylestradiol/Drospirenone in a Real-World Setting: A Prospective Observational Study. Adv Ther. 2022 Nov;39(11):5087-5104. doi: 10.1007/s12325-022-02301-3. Epub 2022 Sep 2.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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 Endometriosis and Dysmenorrhea, run by Bayer at 1 site in Japan.
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 16 Nov 2022. 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 Japan. 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?
Number of adverse drug reactions (ADRs) (time frame: Up to 2 years ( 1 year at the earliest)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03126747, which also lists 1 linked publication.
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 Nov 2022.