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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT04438733
Eligibility Criteria:
Inclusion Criteria:
* Healthy Postmenopausal volunteers aged between 18 and 65 years old.
* The body mass index is in the range of 19.0-28.0 kg/m2 (including the critical value). The weight is not less than 45 kg.
* The subjects have no family planning within 6 months and could select contraceptive method.
* Subjects who had not any medical history of cardiovascular, digestive, respiratory, nervous, haemal diseases or hepatic/renal impairment.
Exclusion Criteria:
* Meet the diagnostic criteria for osteoporosis.
* Subjects with vaginal bleeding.
* blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening.
* any use of other prescription drugs (including contraceptive) 28 days prior to medication for this study.
* any history of alcohol abuse in the recent 2 years or moderate drinkers (drink more 2 units per day or 14 units per week);
* smoking more than 5 cigarettes per day during the 3 months prior to screening;
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04438733
Study Brief:
Protocol Section:
NCT04438733