Status:
COMPLETED
Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
Lead Sponsor:
Chen Yi Enterprise, Co., Ltd.
Conditions:
Dysmenorrhea
Eligibility:
FEMALE
13-40 years
Phase:
NA
Brief Summary
To evaluate the mean change in menstrual pain intensity during menstrual cycles from baseline after wearing Nanoone Woman Underwear in women with primary dysmenorrhea
Detailed Description
The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain). Subjects will be asked to use the VAS scoring system to rec...
Eligibility Criteria
Inclusion
- Females aged below 40 years old.
- Screened by inquiry and diagnosed as primary dysmenorrhea by gynaecologist with pelvic ultrasonography.
- Female subject who is:
- using adequate contraception since last menstruation and no plan for conception during the study.
- non-lactating.
- has negative pregnancy test (urine) within 14 days prior to the study.
- Informed consent form signed.
Exclusion
- Sensitivity to study product.
- Patient has been diagnosed with secondary dysmenorrhea (defined as identifiable pelvic pathology).
- Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co-investigator.
- Participation of any clinical investigation during the last 30 days.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01449305
Start Date
October 1 2011
End Date
June 1 2012
Last Update
February 4 2013
Active Locations (1)
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1
PingTung Christian Hospital
Pingtung City, Taiwan