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:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT02792504
Eligibility Criteria:
Inclusion Criteria:
1. Severe post menopausal vasomotor symptoms with uterus
2. postmenopausal osteopenia
Exclusion Criteria:
* Women with undiagnosed abnormal uterine bleeding
* Women with known, suspected, or past history of breast cancer
* Women with known or suspected estrogen-dependent neoplasia
* Women with active deep venous thrombosis, pulmonary embolism, or history of these conditions
* Women with active arterial thromboembolic disease (for example, stroke, myocardial infarction) or history of these conditions
* Women who are receiving progestin, estrogen, or estrogen-agonists/antagonists
* Women with hypersensitivity (for example, anaphylaxis, angioedema) to estrogens, bazedoxifene, or any ingredients
* Women with known hepatic impairment or disease
* Women with known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders
* Pregnant women, women who may become pregnant, and nursing mothers
* Women with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Study:
NCT02792504
Study Brief:
Protocol Section:
NCT02792504