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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041802

Enrollment

350

Registered

2020-09-15

Start date

2020-09-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary and secondary dysmenorrhea

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactAtsushi Mizukami

Mebix, Inc. Research Promotion Division and Research Planning Group

mizukami@mebix.co.jp03-4362-4500

Outcome results