Survey on Menstrual Symptoms, Health Related Quality of Life and Work Productivity in Patients Su… (NCT04607382) | Clinical Trial Compass
CompletedNot Applicable
Survey on Menstrual Symptoms, Health Related Quality of Life and Work Productivity in Patients Suffering From Pain During Menstruation (Dysmenorrhea) in Japan
Japan397 participantsStarted 2020-09-23
Plain-language 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.
Who can participate
Age range
16 Years – 39 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 exclusion criteria will not be enrolled in this study.
* Patients who have taken LEP for dysmenorrhea in the last 2 months before enrollment\*
* Patients wi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in Menstrual Distress: evaluated by modified Menstrual Distress Questionnaire (mMDQ)
Timeframe: Baseline, 60 days and 120 days
2
Changes in Health Related Quality of Life (HRQoL): evaluated by Short Form (36) Health Survey version 2 (SF-36v2)
Timeframe: Baseline, 60 days and 120 days
3
Changes in work productivity (mWPAI)
Timeframe: Baseline, 60 days and 120 days
4
Changes in Activity Impairment: evaluated by General Health v2.0 (WPAI-GH)