Clinical trial NCT04607382: Survey on Menstrual Symptoms, Health Related Quality of Life and Work Productivity in Patients Suffering From Pain During Menstruation (Dysmenorrhea) in Japan
Official title: Patient Panel Survey on Menstrual Symptoms, HRQoL and Work Productivity in Patients With Primary or Secondary Dysmenorrhea in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysmenorrhea
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-10-29
Enrollment: 397
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is a prospective, non-interventional study for patients being treated for primary or secondary dysmenorrhea in real-world clinical practice. Patients will be recruited using M3 group network. M3 is a company that provides a medical portal site for HCPs, and more than 280,000 medical doctors are registered with M3 with 80% coverage in Japan. As many patients with dysmenorrhea visit ob/gyn clinics rather than hospitals, patients diagnosed as primary or secondary dysmenorrhea will be recruited by gynecologists who work in the clinics enrolled in M3. When patients agree to participate in the study, the gynecologists provide the QR code or URL to the patients enabling them to access the site from their mobile communication equipment such as mobile phones and tablets, and answer the questionnaire.

Brief 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.


Eligibility criteria: 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 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

Primary outcomes:
measure: Changes in Menstrual Distress: evaluated by modified Menstrual Distress Questionnaire (mMDQ)
timeFrame: Baseline, 60 days and 120 days
measure: 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
measure: Changes in work productivity (mWPAI)
timeFrame: Baseline, 60 days and 120 days
measure: Changes in Activity Impairment: evaluated by General Health v2.0 (WPAI-GH)
timeFrame: Baseline, 60 days and 120 days
Secondary outcomes:
measure: Description of patients' background and medical history of LEP and Non-LEP cohorts
timeFrame: Baseline
measure: Change in mMDQ of Non-LEP cohort
timeFrame: Baseline, 60 days and 120 days
measure: Change in HRQoL of Non-LEP cohort
timeFrame: Baseline, 60 days and 120 days
measure: Change in work productivity of Non-LEP cohort
timeFrame: Baseline, 60 days and 120 days
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Multiple Facilities
Study officials:
References:
citation: Yoshino O, Takahashi N, Suzukamo Y. Menstrual Symptoms, Health-Related Quality of Life, and Work Productivity in Japanese Women with Dysmenorrhea Receiving Different Treatments: Prospective Observational Study. Adv Ther. 2022 Jun;39(6):2562-2577. doi: 10.1007/s12325-022-02118-0. Epub 2022 Apr 1.