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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT01487694
Eligibility Criteria:
Inclusion Criteria:
* Thai women, aged ≥ 40 years
* Peri- or postmenopause
* Moderate to severe menopausal symptoms from Kupperman menopausal index score at least 20
Exclusion Criteria:
* Using any drugs or hormonal treatment within 1 month before enrollment
* BMI ≥ 30 kg/m2
* Allergic to drugs or any ingredient
* Liver disease or AST ≥ 37 U/L or ALT ≥ 40 U/L or total bilirubin ≥ 1 mg/dL or direct bilirubin ≥ 0.3 mg/dL
* Psychiatric disease
* Alcohol consumption or any elicit drug use
* Vegetarian (may consume more phytoestrogen)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT01487694
Study Brief:
Protocol Section:
NCT01487694