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

Patient Panel Survey on Menstrual Symptoms, HRQoL and Work Productivity in Patients With Primary or Secondary Dysmenorrhea in Japan

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.

Study Overview

• Status: Completed
• Conditions: Dysmenorrhea
• Intervention / Treatment: Drug: LEP; Drug: NSAIDs and/or Chinese medicine (CM)

• Study Type: Observational
• Enrollment (Actual): 397

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan
    • Multiple facilities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 37 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; LEP dosage up to the discretion of the treating gynecologists.
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); Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Chinese medicine (CM) dosage up to the discretion of the treating gynecologists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	Baseline, 60 days and 120 days

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: 21420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No