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

NCT ID: NCT04607382

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 397 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-23
• Study Completion Date: 2021-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

LEP

Intervention Type: DRUG

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.

NSAIDs and/or Chinese medicine (CM)

Intervention Type: DRUG

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

Interventions

LEP

LEP dosage up to the discretion of the treating gynecologists.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Multiple Facilities

Multiple Locations, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 35362862 (View on PubMed)

Other Identifiers

21420

Identifier Type: -

Identifier Source: org_study_id