Multiple Facilities
Multiple Locations, Japan
NCT Number: NCT04607382
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.
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Notify Me16 year–39 year
Female
Observational
Multiple Locations, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Exclusion criteria
Patients who meet any of the exclusion criteria will not be enrolled in this study.
Patients with contraindications for LEP or COC are as follows:
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.
Time frame: Baseline, 60 days and 120 days
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
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
To describe the changes in work productivity before, during and after the study in LEP cohort.
Time frame: Baseline, 60 days and 120 days
To describe the changes in activity impairment before, during and after the study in LEP cohort.
Time frame: Baseline
To describe patients' background and medical history of LEP and Non-LEP cohorts
Time frame: Baseline, 60 days and 120 days
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
To describe the change in HRQoL before, during and after the study in Non-LEP cohort.
Time frame: Baseline, 60 days and 120 days
To describe the change in work productivity before, during and after the study in Non-LEP cohort.
Bayer
Industry
Patient Panel Survey on Menstrual Symptoms, HRQoL and Work Productivity in Patients With Primary or Secondary Dysmenorrhea in Japan
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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