DysmenorrheaNCT01375998
YAZ Post-marketing Surveillance in Japan
An observational study of Dysmenorrhea, run by Bayer at 1 site in Japan.
Trial summary
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received YAZ for dysmenorrhea. The objective of this study is to assess safety and efficacy of using YAZ in clinical practice. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- EE20/DRSP(YAZ, BAY86-5300)
- How many people
- 3,273 participants
- Where
- 1 siteJapan
- Study dates
- 9 Jun 2011to 8 Mar 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: The target population of this study is patients who have received a prescription of YAZ on the basis of the decision of the treating gynecologist. The study is expected to collect data of 3,000 patients in about 300 gynecological practices in Japan.
Who may be able to join
- Patients who received YAZ for dysmenorrhea Additional criteria for QOL questionnaire
- Patient informed consent
Who cannot join
- Patients who are contraindicated based on the product label Additional criteria for QOL questionnaire
- Six months or less after treatment of estrogen or estrogen combination drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Use Investigation of YAZ
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received YAZ for dysmenorrhea. The objective of this study is to assess safety and efficacy of using YAZ in clinical practice. A total 3,000 patients will be recruited and followed 3 years since starting YAZ administration.
- Conditions
- Dysmenorrhea
- Being tested
- EE20/DRSP(YAZ, BAY86-5300)
- Keywords
- YAZ, Dysmenorrhea
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EE20/DRSP(YAZ, BAY86-5300)Drug
Patients in daily life treatment receiving YAZ for dysmenorrhea.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: EE20/DRSP(YAZ, BAY86-5300) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reactions and sever adverse events
Measured: During YAZ administration, up to 3 years
Change from baseline in severity of dysmenorrhea at 6th cycles (28 days per cycle)
Measured: Baseline and during YAZ administration, up to 3 years
Secondary outcomes (5)
Incidence of adverse events
Measured: During YAZ administration, up to 3 years
Unpleasant physical symptoms collection
Measured: Baseline and during YAZ administration, up to 3 years
Unpleasant psychological symptoms collection
Measured: Baseline and during YAZ administration, up to 3 years
Analgesic drug for dysmenorrhea
Measured: During YAZ administration, up to 3 years
QOL survey using Short-Form 36-Item Health Survey (SF-36)
Measured: Baseline and at 6th - 8th cycles (28 datys per cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study start9 Jun 2011
- Primary completion5 Dec 2017
- Study completion8 Mar 2018
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 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,273 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
- NCT01375998
- Sponsor's protocol ID
- 15328
- Other IDs
- YAZ-DUI
- Status last verified
- Mar 2019
- First submitted
- 8 Jun 2011
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Momoeda M, Akiyama S, Tanaka K, Suzukamo Y. Quality of Life in Japanese Patients with Dysmenorrhea Treated with Ethinylestradiol 20 mug/Drospirenone 3 mg in a Real-World Setting: An Observational Study. Int J Womens Health. 2020 May 4;12:327-338. doi: 10.2147/IJWH.S238460. eCollection 2020.
PubMed 32440228
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation of YAZ
- ClinicalTrials.gov ID
- NCT01375998
- Acronym / sponsor ID
- 15328
- Conditions
- Dysmenorrhea
- Keywords
- YAZ, Dysmenorrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,273 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2011 (actual)
- Primary completion
- 5 Dec 2017 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 20 Jun 2011 (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 regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received YAZ for dysmenorrhea. The objective of this study is to assess safety and efficacy of using YAZ in clinical practice. A total 3,000 patients will be recruited and followed 3 years since starting YAZ administration.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: EE20/DRSP(YAZ, BAY86-5300) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target population of this study is patients who have received a prescription of YAZ on the basis of the decision of the treating gynecologist. The study is expected to collect data of 3,000 patients in about 300 gynecological practices in Japan.
Key inclusion criteria (2 listed)
- Patients who received YAZ for dysmenorrhea Additional criteria for QOL questionnaire
- Patient informed consent
Key exclusion criteria (2 listed)
- Patients who are contraindicated based on the product label Additional criteria for QOL questionnaire
- Six months or less after treatment of estrogen or estrogen combination drug
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 |
|---|---|---|
| EE20/DRSP(YAZ, BAY86-5300)Patients in daily life treatment receiving YAZ for dysmenorrhea. | Drug | Group 1 |
Primary outcome
Incidence of adverse drug reactions and sever adverse events
Time frame: During YAZ administration, up to 3 years
Change from baseline in severity of dysmenorrhea at 6th cycles (28 days per cycle)
Time frame: Baseline and during YAZ administration, up to 3 years
5 secondary outcomes
Incidence of adverse events
Time frame: During YAZ administration, up to 3 years
Unpleasant physical symptoms collection
Time frame: Baseline and during YAZ administration, up to 3 years
Unpleasant psychological symptoms collection
Time frame: Baseline and during YAZ administration, up to 3 years
Analgesic drug for dysmenorrhea
Time frame: During YAZ administration, up to 3 years
QOL survey using Short-Form 36-Item Health Survey (SF-36)
Time frame: Baseline and at 6th - 8th cycles (28 datys per cycle)
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 2019.
- Derived from this study: PubMed 32440228Momoeda M, Akiyama S, Tanaka K, Suzukamo Y. Quality of Life in Japanese Patients with Dysmenorrhea Treated with Ethinylestradiol 20 mug/Drospirenone 3 mg in a Real-World Setting: An Observational Study. Int J Womens Health. 2020 May 4;12:327-338. doi: 10.2147/IJWH.S238460. eCollection 2020.
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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 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 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 7 Mar 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 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?
Incidence of adverse drug reactions and sever adverse events (time frame: During YAZ administration, up to 3 years). 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?
On the ClinicalTrials.gov record for NCT01375998, 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 7 Mar 2019.