check_circleStudy Completed

Dysmenorrhea

Bayer Identifier:

21420

ClinicalTrials.gov Identifier:

NCT04607382

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

Female

Age

16 - 39 Years
  • 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.

    :
    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
  • 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 with mental disorders such as depression, severe infectious diseases, or malignant tumors
    - Patients who do not meet the inclusion criteria.
    Patients with contraindications for LEP or COC are as follows:
    - Women who have a predisposition to hypersensitivity to the ingredients of this product
    - Breast cancer patients
    - Patients with undiagnosed abnormal genital bleeding
    - Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, coronary artery disease, or a history of the same
    - Smokers over the age of 35 who smoke more than 15 cigarettes a day
    - Patients with migraine with antecedents (flashing lights, star-shaped flashes, etc.)
    - Patients with valvular heart disease complicated by pulmonary hypertension or atrial fibrillation and with a history of subacute bacterial endocarditis
    - Diabetic patients with vascular lesions (diabetic nephropathy, diabetic retinopathy, etc.)
    - Patients with thrombotic predisposition
    - Patients with antiphospholipid antibody syndrome
    - Patients with major surgeries of 30 minutes or more, within 4 weeks before surgery, within 2 weeks after surgery, and in patients with long-term rest
    - Patients with severe liver damage.
    - Patients with liver tumors
    - Hypertension (except for patients with mild hypertension)
    - Otosclerosis
    - Patients with a history of jaundice, persistent pruritus, or herpes pregnancy during pregnancy
    - Women who are pregnant or who may be pregnant
    - Breastfeeding women under 6 months of age
    - Patients taking contraindicated drugs for LEP or COC

Trial summary

Enrollment Goal
397
Trial Dates
September 2020 - June 2021
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Multiple FacilitiesMany 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 cohorts
    To describe patients’ background and medical history of LEP and Non-LEP cohorts
    date_rangeTime Frame:
    Baseline
  • Change in mMDQ of Non-LEP cohort
    To 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 cohort
    To 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 cohort
    To 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

Patient panel survey on menstrual symptoms, HRQoL and work productivity in patients with primary or secondary dysmenorrhea in Japan
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A