Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT01449305
Eligibility Criteria:
Inclusion Criteria:
1. Females aged below 40 years old.
2. Screened by inquiry and diagnosed as primary dysmenorrhea by gynaecologist with pelvic ultrasonography.
3. 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.
4. Informed consent form signed.
Exclusion Criteria:
1. Sensitivity to study product.
2. Patient has been diagnosed with secondary dysmenorrhea (defined as identifiable pelvic pathology).
3. Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co-investigator.
4. Participation of any clinical investigation during the last 30 days.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
13 Years
Maximum Age:
40 Years
Study:
NCT01449305
Study Brief:
Protocol Section:
NCT01449305