Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEP | Drug | LEP dosage up to the discretion of the treating gynecologists. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Baseline, 60 days and 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| Change in mMDQ of Non-LEP cohort |
Not provided
Female patients with a diagnosis of dysmenorrhea will be enrolled after the decision for treatment with LEP or Non-LEP has been made by the physician. Patients who have been prescribed LEP or Non-LEP for a medically appropriate use will be eligible to be enrolled. Indications and contraindications according to the local market authorization should be carefully considered. Evidence of assessment of all eligibility criteria by the patients, as well as enrollment of a patient in the study should be documented in database of M3.
Inclusion Criteria:
Patients who meet all the inclusion criteria will be enrolled in this study.
Exclusion Criteria:
Patients who meet any of the exclusion criteria will not be enrolled in this study.
Patients with contraindications for LEP or COC are as follows:
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Facilities | Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35362862 | Derived | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
To describe the change in menstrual symptoms before, during and after the study in Non-LEP cohort.
| 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. | 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. | Baseline, 60 days and 120 days |
| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided