check_circleStudy Completed
Dysmenorrhea
Bayer Identifier:
21420
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Survey on menstrual symptoms, Health Related Quality of Life and work productivity in patients suffering from pain during menstruation (dysmenorrhea) in Japan
Trial purpose
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.
Key Participants Requirements
Sex
FemaleAge
16 - 39 YearsTrial summary
Enrollment Goal
397Trial Dates
September 2020 - June 2021Phase
N/ACould I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Multiple Facilities | Many Locations, Japan |
Primary Outcome
- Changes in Menstrual Distress: evaluated by modified Menstrual Distress Questionnaire (mMDQ)To describe the changes in menstrual symptoms before, during and after the study in Low-dose Estrogen Progestin product (LEP) cohort.date_rangeTime Frame:Baseline, 60 days and 120 days
- Changes in Health Related Quality of Life (HRQoL): evaluated by Short Form (36) Health Survey version 2 (SF-36v2)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.date_rangeTime Frame:Baseline, 60 days and 120 days
- Changes in work productivity (mWPAI)To describe the changes in work productivity before, during and after the study in LEP cohort.date_rangeTime Frame:Baseline, 60 days and 120 days
- Changes in Activity Impairment: evaluated by General Health v2.0 (WPAI-GH)To describe the changes in activity impairment before, during and after the study in LEP cohort.date_rangeTime Frame:Baseline, 60 days and 120 days
Secondary Outcome
- Description of patients’ background and medical history of LEP and Non-LEP cohortsTo describe patients’ background and medical history of LEP and Non-LEP cohortsdate_rangeTime Frame:Baseline
- Change in mMDQ of Non-LEP cohortTo describe the change in menstrual symptoms before, during and after the study in Non-LEP cohort.date_rangeTime Frame:Baseline, 60 days and 120 days
- Change in HRQoL of Non-LEP cohortTo describe the change in HRQoL before, during and after the study in Non-LEP cohort.date_rangeTime Frame:Baseline, 60 days and 120 days
- Change in work productivity of Non-LEP cohortTo describe the change in work productivity before, during and after the study in Non-LEP cohort.date_rangeTime Frame:Baseline, 60 days and 120 days
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A