Unique ID issued by UMIN | UMIN000041802 |
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Receipt number | R000047716 |
Scientific Title | 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 Japan |
Date of disclosure of the study information | 2020/09/15 |
Last modified on | 2024/03/18 10:22:27 |
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 Japan
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 Japan
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 Japan
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 Japan
Japan |
Primary and secondary dysmenorrhea
Obstetrics and Gynecology |
Others
NO
To describe changes in menstrual symptoms, HRQoL, and work productivity before and after treatment in dysmenorrhea patients treated with LEP
Others
1) To describe patients' background and medical history of dysmenorrhea patients treated with LEP and Non-LEP such as NSAIDs and TCM
2) To investigate menstrual symptoms, HRQoL, and work productivity at baseline and treatment period in Non-LEP cohort as well as patients' background and medical history as a reference
Exploratory
Explanatory
Not applicable
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.
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.
Observational
16 | years-old | <= |
39 | years-old | >= |
Male and Female
Patients who meet all the inclusion criteria will be enrolled in this study.
1) Patients between the ages of 16 and 39
2) Patients diagnosed with primary or secondary dysmenorrhea by gynecologists
3) Patients who can visit ob/gyn clinics or hospitals every 6 months to have consultations with gynecologists for treatment of dysmenorrhea
4) Patients who plan to be treated with drug for dysmenorrhea after enrollment in this study
5) Patients who can access the website to complete the questionnaire using mobile communication equipment such as mobile phones or tablets
6) Patients who submit an informed consent on the website before the start of this study
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)
350
1st name | Yasuko |
Middle name | |
Last name | Aitoku |
Bayer Yakuhin, Ltd.
Market Access
530-0001
2-4-9 Umeda, Kita-ku, Osaka City, Osaka, Japan
06-6133-6397
yasuko.aitoku@bayer.com
1st name | Atsushi |
Middle name | |
Last name | Mizukami |
Mebix, Inc.
Research Promotion Division and Research Planning Group
105-0001
Toranomon 33 Mori Building, 3-8-21 Toranomon, Minato-ku, Tokyo, Japan
03-4362-4500
mizukami@mebix.co.jp
Bayer Yakuhin, Ltd.
Bayer Yakuhin, Ltd.
Profit organization
Institutional Review Board of Takahashi Clinic
5-1-31 Iwayakita-machi, Nada-ku, Kobe City, Hyogo, Japan
078-882-6432
kishimoto.satoshi@neues.co.jp
NO
2020 | Year | 09 | Month | 15 | Day |
Unpublished
495
Main results already published
2020 | Year | 09 | Month | 09 | Day |
2020 | Year | 09 | Month | 18 | Day |
2020 | Year | 09 | Month | 18 | Day |
2020 | Year | 11 | Month | 30 | Day |
2021 | Year | 03 | Month | 31 | Day |
Study visits were defined as Enrollment (Day 1), Follow-up time (Day 60), and Final follow-up time (Day 120) with an observational period of 120 days.
The data to be collected in this study are as follows; patients background, follow-up data such as treatment of dysmenorrhea and menstruation-related information, and questionnaire such as mMDQ, SF-36v2, and mWPAI-GH.
2020 | Year | 09 | Month | 15 | Day |
2024 | Year | 03 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047716
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