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

• ClinicalTrials.gov Identifier: NCT04607382
• Recruitment Status: Completed
• First Posted: October 29, 2020
• Last Update Posted: August 11, 2021
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment
Dysmenorrhea	Drug: LEP; Drug: NSAIDs and/or Chinese medicine (CM)

Study Design

• Study Type: Observational
• Actual Enrollment: 397 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Patient Panel Survey on Menstrual Symptoms, HRQoL and Work Productivity in Patients With Primary or Secondary Dysmenorrhea in Japan
• Actual Study Start Date: September 23, 2020
• Actual Primary Completion Date: June 30, 2021
• Actual Study Completion Date: June 30, 2021

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Changes in Menstrual Distress: evaluated by modified Menstrual Distress Questionnaire (mMDQ) [ Time Frame: Baseline, 60 days and 120 days ]
   To describe the changes in menstrual symptoms before, during and after the study in Low-dose Estrogen Progestin product (LEP) cohort.
2. Changes in Health Related Quality of Life (HRQoL): evaluated by Short Form (36) Health Survey version 2 (SF-36v2) [ Time Frame: Baseline, 60 days and 120 days ]

   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.

3. Changes in work productivity (mWPAI) [ Time Frame: Baseline, 60 days and 120 days ]
   To describe the changes in work productivity before, during and after the study in LEP cohort.
4. Changes in Activity Impairment: evaluated by General Health v2.0 (WPAI-GH) [ Time Frame: Baseline, 60 days and 120 days ]
   To describe the changes in activity impairment before, during and after the study in LEP cohort.

Secondary Outcome Measures :

1. Description of patients' background and medical history of LEP and Non-LEP cohorts [ Time Frame: Baseline ]
   To describe patients' background and medical history of LEP and Non-LEP cohorts
2. Change in mMDQ of Non-LEP cohort [ Time Frame: Baseline, 60 days and 120 days ]
   To describe the change in menstrual symptoms before, during and after the study in Non-LEP cohort.
3. Change in HRQoL of Non-LEP cohort [ Time Frame: Baseline, 60 days and 120 days ]
   To describe the change in HRQoL before, during and after the study in Non-LEP cohort.
4. Change in work productivity of Non-LEP cohort [ Time Frame: Baseline, 60 days and 120 days ]
   To describe the change in work productivity before, during and after the study in Non-LEP cohort.

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 39 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

Japan

Multiple Facilities

Multiple Locations, Japan

Sponsors and Collaborators

Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT04607382
• Other Study ID Numbers: 21420
• First Posted: October 29, 2020
• Last Update Posted: August 11, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dysmenorrhea; Menstruation Disturbances; Pathologic Processes; Pelvic Pain; Pain; Neurologic Manifestations