Dysmenorrhea
Conditions
Brief 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. 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.
Interventions
DRUGLEP
LEP dosage up to the discretion of the treating gynecologists.
DRUGNSAIDs and/or Chinese medicine (CM)
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Chinese medicine (CM) dosage up to the discretion of the treating gynecologists.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
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. * 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
Exclusion criteria
Patients who meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Activity Impairment: evaluated by General Health v2.0 (WPAI-GH) | Baseline, 60 days and 120 days | To describe the changes in activity impairment before, during and after the study in LEP cohort. |
| Changes in Menstrual Distress: evaluated by modified Menstrual Distress Questionnaire (mMDQ) | 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) | 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) | Baseline, 60 days and 120 days | To describe the changes in work productivity before, during and after the study in LEP cohort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of patients' background and medical history of LEP and Non-LEP cohorts | Baseline | To describe patients' background and medical history of LEP and Non-LEP cohorts |
| Change in mMDQ of Non-LEP cohort | Baseline, 60 days and 120 days | To describe the change in menstrual symptoms before, during and after the study in Non-LEP cohort. |
| Change in HRQoL of Non-LEP cohort | Baseline, 60 days and 120 days | To describe the change in HRQoL before, during and after the study in Non-LEP cohort. |
| Change in work productivity of Non-LEP cohort | Baseline, 60 days and 120 days | To describe the change in work productivity before, during and after the study in Non-LEP cohort. |
Countries
Japan
Outcome results
None listed