A prospective observational study on menstrual symptoms, HRQoL, and work productivity in patients with primary or secondary dysmenorrhea before, during, and after treatment with LEP or non-LEP in Japa
Not Applicable
- Conditions
- Primary and secondary dysmenorrhea
- Registration Number
- JPRN-UMIN000041802
- Lead Sponsor
- Bayer Yakuhin, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 495
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who meet any of the exclusion criteria will not be enrolled in this study. 1) Patients who have taken LEP for dysmenorrhea in the last 2 months before enrollment 2) Patients with mental disorders such as depression, severe infectious diseases, or malignant tumors 3) Patients with contraindications for LEP or COC 4) Patients who deemed by the investigators to be unsuitable for inclusion in the study (e.g., patients using hormonal agents other than LEP)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The changes in the modified Menstrual Distress Questionnaire (mMDQ), the Short Form (36) Health Survey version 2 (SF-36v2), and the modified Work Productivity and Activity Impairment Questionnaire (mWPAI) after the treatment in patients treated with LEP, compared with before treatment.
- Secondary Outcome Measures
Name Time Method 1) Patient background and medical history in patients treated with LEP and Non-LEP at baseline. 2) The changes in the mMDQ, SF-36v2, and mWPAI after the treatment in patients treated with Non-LEP, compared with before treatment.