N/A
N=44
Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
Dysmenorrhea
Bottom Line
View on ClinicalTrials.gov: NCT01449305 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline — -0.810; -1.29; -1.74 scores
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nanoone Woman Underwear (Device)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- Female
- Sponsor
- Chen Yi Enterprise, Co., Ltd.
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline |
-0.810; -1.29; -1.74 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01449305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.