N/A
Completed N=44
Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
Source: ClinicalTrials.gov NCT01449305 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcomePrimary: The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline — -0.810; -1.29; -1.74 scores
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
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 | — |
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. Informational only — not medical advice.