Survey on Menstrual Symptoms, Health Related Quality of Life and Work Productivity in Patients Suffering From Pain During Menstruation (Dysmenorrhea) in Japan

NCT04607382 | Completed

• 1 other identifier: 21420
• Study Type: observational
• Target: 397
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, 60 days and 120 days

Secondary Outcomes (4)

• Description of patients' background and medical history of LEP and Non-LEP cohorts

  Baseline

• Change in mMDQ of Non-LEP cohort

  Baseline, 60 days and 120 days

• Change in HRQoL of Non-LEP cohort

  Baseline, 60 days and 120 days

• Change in work productivity of Non-LEP cohort

  Baseline, 60 days and 120 days

Study Arms (2)

Low-dose estrogen progestin products (LEP)

The patients in the LEP cohort should not have taken LEP in the last 2 months before the enrollment in the study, and will take LEP during the study period.

Drug: LEP

Non-LEP

Those patients in the Non-LEP cohort should not have taken LEP in the last 2 months before the enrollment and will take NSAIDs and/or Chinese medicine (CM) during the study period.

Drug: NSAIDs and/or Chinese medicine (CM)

Interventions

LEP DRUG

LEP dosage up to the discretion of the treating gynecologists.

Low-dose estrogen progestin products (LEP)

NSAIDs and/or Chinese medicine (CM) DRUG

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Chinese medicine (CM) dosage up to the discretion of the treating gynecologists.

Non-LEP

Eligibility Criteria

• Age: 16 Years - 39 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Multiple Facilities

Multiple Locations, Japan

Location

Related Publications (1)

• 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.

  PMID: 35362862 DERIVED

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 29, 2020
• Study Start: September 23, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)