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 Type
OBSERVATIONAL
Enrollment
397
LEP dosage up to the discretion of the treating gynecologists.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Chinese medicine (CM) dosage up to the discretion of the treating gynecologists.
Multiple Facilities
Multiple Locations, Japan
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 60 days and 120 days
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 60 days and 120 days
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