Trial Condition(s):

Dysmenorrhea

Survey on menstrual symptoms, Health Related Quality of Life and work productivity in patients suffering from pain during menstruation (dysmenorrhea) in Japan

Bayer Identifier:

21420

ClinicalTrials.gov Identifier:

NCT04607382

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
397
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Unspecified
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Multiple Facilities

Many Locations, Japan

Status
Completed
 

Trial Design