DysmenorrheaNCT04607382
Survey on Menstrual Symptoms, Health Related Quality of Life and Work Productivity in Patients Suffering From Pain During Menstruation (Dysmenorrhea) in Japan
An observational study of Dysmenorrhea, run by Bayer at 1 site in Japan.
Trial summary
In this study researcher want to gain more information on the treatment effect of Low-dose Estrogen Progestin (a hormone treatment) on the health related quality of life and work productivity in patients suffering from menstrual pain. Read more about this study
- Who is it for?
- Ages 16 to 39 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- LEP and NSAIDs and/or Chinese medicine (CM)
- How many people
- 397 participants
- Where
- 1 siteJapan
- Study dates
- 23 Sep 2020to 30 Jun 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 16 to 39 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The study is a prospective, non-interventional study for patients being treated for primary or secondary dysmenorrhea in real-world clinical practice. Patients will be recruited using M3 group network. M3 is a company that provides a medical portal site for HCPs, and more than 280,000 medical doctors are registered with M3 with 80% coverage in Japan. As many patients with dysmenorrhea visit ob/gyn clinics rather than hospitals, patients diagnosed as primary or secondary dysmenorrhea will be recruited by gynecologists who work in the clinics enrolled in M3. When patients agree to participate in the study, the gynecologists provide the QR code or URL to the patients enabling them to access the site from their mobile communication equipment such as mobile phones and tablets, and answer the questionnaire.
Who may be able to join
- Patients who meet all the inclusion criteria will be enrolled in this study.
- Patients between the ages of 16 and 39
- Patients diagnosed with primary or secondary dysmenorrhea by gynecologists
- Patients who can visit ob/gyn clinics or hospitals every 6 months to have consultations with gynecologists for treatment of dysmenorrhea
- Patients who plan to be treated with drug for dysmenorrhea after enrollment in this study
- Patients who are currently on Non-LEP therapies will be eligible for LEP cohort**
- Patients who can access the website to complete the questionnaire using mobile communication equipment such as mobile phones or tablets
- Patients who submit an informed consent on the website before the start of this study
Who cannot join
- Patients who meet any of the exclusion criteria will not be enrolled in this study.
- Patients who have taken LEP for dysmenorrhea in the last 2 months before enrollment*
- Patients with mental disorders such as depression, severe infectious diseases, or malignant tumors
- Patients who do not meet the inclusion criteria.
- Patients with contraindications for LEP or COC are as follows:
- Women who have a predisposition to hypersensitivity to the ingredients of this product
Show all 24Show fewer
- Breast cancer patients
- Patients with undiagnosed abnormal genital bleeding
- Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, coronary artery disease, or a history of the same
- Smokers over the age of 35 who smoke more than 15 cigarettes a day
- Patients with migraine with antecedents (flashing lights, star-shaped flashes, etc.)
- Patients with valvular heart disease complicated by pulmonary hypertension or atrial fibrillation and with a history of subacute bacterial endocarditis
- Diabetic patients with vascular lesions (diabetic nephropathy, diabetic retinopathy, etc.)
- Patients with thrombotic predisposition
- Patients with antiphospholipid antibody syndrome
- Patients with major surgeries of 30 minutes or more, within 4 weeks before surgery, within 2 weeks after surgery, and in patients with long-term rest
- Patients with severe liver damage.
- Patients with liver tumors
- Hypertension (except for patients with mild hypertension)
- Otosclerosis
- Patients with a history of jaundice, persistent pruritus, or herpes pregnancy during pregnancy
- Women who are pregnant or who may be pregnant
- Breastfeeding women under 6 months of age
- Patients taking contraindicated drugs for LEP or COC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Panel Survey on Menstrual Symptoms, HRQoL and Work Productivity in Patients With Primary or Secondary Dysmenorrhea in Japan
In this study researcher want to gain more information on the treatment effect of Low-dose Estrogen Progestin (a hormone treatment) on the health related quality of life and work productivity in patients suffering from menstrual pain. The treating doctors will ask the study participants to complete questionnaires at start of study, after 2 and 4 months (end of study). The questions will be about participant's general and mental health, concentration, behavioral and emotional changes, and work productivity and activity level. This study will be conducted in Japan and enrols about 380 female participants in the age range of 16 to 39 years.
- Conditions
- Dysmenorrhea
- Being tested
- LEP, NSAIDs and/or Chinese medicine (CM)
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEPDrug
LEP dosage up to the discretion of the treating gynecologists.
NSAIDs and/or Chinese medicine (CM)Drug
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Chinese medicine (CM) dosage up to the discretion of the treating gynecologists.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose estrogen progestin products (LEP) | The patients in the LEP cohort should not have taken LEP in the last 2 months before the enrollment in the study, and will take LEP during the study period. Receives: Drug: LEP | |
| Non-LEP | Those patients in the Non-LEP cohort should not have taken LEP in the last 2 months before the enrollment and will take NSAIDs and/or Chinese medicine (CM) during the study period. Receives: Drug: NSAIDs and/or Chinese medicine (CM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Menstrual Distress: evaluated by modified Menstrual Distress Questionnaire (mMDQ)
To describe the changes in menstrual symptoms before, during and after the study in Low-dose Estrogen Progestin product (LEP) cohort.
Measured: Baseline, 60 days and 120 days
Changes in Health Related Quality of Life (HRQoL): evaluated by Short Form (36) Health Survey version 2 (SF-36v2)
To describe the changes in HRQoL before, during and after the study in LEP cohort.
The SF-36v2 will be assessed on a 3- and 5-point Likert scale. The rating scale depends on each question.
Measured: Baseline, 60 days and 120 days
Changes in work productivity (mWPAI)
To describe the changes in work productivity before, during and after the study in LEP cohort.
Measured: Baseline, 60 days and 120 days
Changes in Activity Impairment: evaluated by General Health v2.0 (WPAI-GH)
To describe the changes in activity impairment before, during and after the study in LEP cohort.
Measured: Baseline, 60 days and 120 days
Secondary outcomes (4)
Description of patients' background and medical history of LEP and Non-LEP cohorts
To describe patients' background and medical history of LEP and Non-LEP cohorts
Measured: Baseline
Change in mMDQ of Non-LEP cohort
To describe the change in menstrual symptoms before, during and after the study in Non-LEP cohort.
Measured: Baseline, 60 days and 120 days
Change in HRQoL of Non-LEP cohort
To describe the change in HRQoL before, during and after the study in Non-LEP cohort.
Measured: Baseline, 60 days and 120 days
Change in work productivity of Non-LEP cohort
To describe the change in work productivity before, during and after the study in Non-LEP cohort.
Measured: Baseline, 60 days and 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start23 Sep 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 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 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
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607382
- Sponsor's protocol ID
- 21420
- Status last verified
- Jun 2022
- First submitted
- 18 Sep 2020
- Last updated
- 30 Jun 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 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Publications
Yoshino O, Takahashi N, Suzukamo Y. Menstrual Symptoms, Health-Related Quality of Life, and Work Productivity in Japanese Women with Dysmenorrhea Receiving Different Treatments: Prospective Observational Study. Adv Ther. 2022 Jun;39(6):2562-2577. doi: 10.1007/s12325-022-02118-0. Epub 2022 Apr 1.
PubMed 35362862
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Panel Survey on Menstrual Symptoms, HRQoL and Work Productivity in Patients With Primary or Secondary Dysmenorrhea in Japan
- ClinicalTrials.gov ID
- NCT04607382
- Acronym / sponsor ID
- 21420
- Conditions
- Dysmenorrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 29 Oct 2020 (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.
In this study researcher want to gain more information on the treatment effect of Low-dose Estrogen Progestin (a hormone treatment) on the health related quality of life and work productivity in patients suffering from menstrual pain. The treating doctors will ask the study participants to complete questionnaires at start of study, after 2 and 4 months (end of study). The questions will be about participant's general and mental health, concentration, behavioral and emotional changes, and work productivity and activity level. This study will be conducted in Japan and enrols about 380 female participants in the age range of 16 to 39 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose estrogen progestin products (LEP) | – | Drug: LEPThe patients in the LEP cohort should not have taken LEP in the last 2 months before the enrollment in the study, and will take LEP during the study period. |
| Non-LEP | – | Drug: NSAIDs and/or Chinese medicine (CM)Those patients in the Non-LEP cohort should not have taken LEP in the last 2 months before the enrollment and will take NSAIDs and/or Chinese medicine (CM) during the study period. |
Who may qualify
- Ages
- 16 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study is a prospective, non-interventional study for patients being treated for primary or secondary dysmenorrhea in real-world clinical practice. Patients will be recruited using M3 group network. M3 is a company that provides a medical portal site for HCPs, and more than 280,000 medical doctors are registered with M3 with 80% coverage in Japan. As many patients with dysmenorrhea visit ob/gyn clinics rather than hospitals, patients diagnosed as primary or secondary dysmenorrhea will be recruited by gynecologists who work in the clinics enrolled in M3. When patients agree to participate in the study, the gynecologists provide the QR code or URL to the patients enabling them to access the site from their mobile communication equipment such as mobile phones and tablets, and answer the questionnaire.
Key inclusion criteria (8 listed)
- Patients who meet all the inclusion criteria will be enrolled in this study.
- Patients between the ages of 16 and 39
- Patients diagnosed with primary or secondary dysmenorrhea by gynecologists
- Patients who can visit ob/gyn clinics or hospitals every 6 months to have consultations with gynecologists for treatment of dysmenorrhea
- Patients who plan to be treated with drug for dysmenorrhea after enrollment in this study
Key exclusion criteria (24 listed)
- Patients who meet any of the exclusion criteria will not be enrolled in this study.
- Patients who have taken LEP for dysmenorrhea in the last 2 months before enrollment*
- Patients with mental disorders such as depression, severe infectious diseases, or malignant tumors
- Patients who do not meet the inclusion criteria.
- Women who have a predisposition to hypersensitivity to the ingredients of this product
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 |
|---|---|---|
| LEPLEP dosage up to the discretion of the treating gynecologists. | Drug | Low-dose estrogen progestin products (LEP) |
| NSAIDs and/or Chinese medicine (CM)Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Chinese medicine (CM) dosage up to the discretion of the treating gynecologists. | Drug | Non-LEP |
Primary outcome
Changes in Menstrual Distress: evaluated by modified Menstrual Distress Questionnaire (mMDQ)
Time frame: Baseline, 60 days and 120 days
To describe the changes in menstrual symptoms before, during and after the study in Low-dose Estrogen Progestin product (LEP) cohort.
Changes in Health Related Quality of Life (HRQoL): evaluated by Short Form (36) Health Survey version 2 (SF-36v2)
Time frame: Baseline, 60 days and 120 days
To describe the changes in HRQoL before, during and after the study in LEP cohort. The SF-36v2 will be assessed on a 3- and 5-point Likert scale. The rating scale depends on each question.
Changes in work productivity (mWPAI)
Time frame: Baseline, 60 days and 120 days
To describe the changes in work productivity before, during and after the study in LEP cohort.
Changes in Activity Impairment: evaluated by General Health v2.0 (WPAI-GH)
Time frame: Baseline, 60 days and 120 days
To describe the changes in activity impairment before, during and after the study in LEP cohort.
4 secondary outcomes
Description of patients' background and medical history of LEP and Non-LEP cohorts
Time frame: Baseline
Change in mMDQ of Non-LEP cohort
Time frame: Baseline, 60 days and 120 days
Change in HRQoL of Non-LEP cohort
Time frame: Baseline, 60 days and 120 days
Change in work productivity of Non-LEP cohort
Time frame: Baseline, 60 days and 120 days
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 30 Jun 2022.
- Derived from this study: PubMed 35362862Yoshino O, Takahashi N, Suzukamo Y. Menstrual Symptoms, Health-Related Quality of Life, and Work Productivity in Japanese Women with Dysmenorrhea Receiving Different Treatments: Prospective Observational Study. Adv Ther. 2022 Jun;39(6):2562-2577. doi: 10.1007/s12325-022-02118-0. Epub 2022 Apr 1.
- Individual participant dataSharing planned: No. Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors 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.
The record lists no contact. Use the official record to reach the sponsor.
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 8 inclusion and 24 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 30 Jun 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?
Changes in Menstrual Distress: evaluated by modified Menstrual Distress Questionnaire (mMDQ) (time frame: Baseline, 60 days and 120 days). The study lists 4 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 NCT04607382, 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 30 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.