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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT01579734
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal women candidates to HRT for control of menopausal symptoms or prevention of postmenopausal disorders. women currently undergoing HRT for any duration; (women off HRT for 1 year or longer are considered de novo users);
* negative bilateral mammography (within the last 6 months);
* written informed consent.
Exclusion Criteria:
Any type of malignancy, with the exclusion of CIN and non-melanoma skin cancer;
* active proliferative disorders of the endometrium such as atypical hyperplasia, history of active endometriosis, unresected polyps, symptomatic myomata;
* alterations of metabolic, liver, renal and cardiac grade 2 function (NCI criteria grade 2 or higher);
* any type of retinal disorders, severe cataract and glaucoma;
* presence of significant risk factors for venous events, including immobilization within the last 3 months for longer than 2 weeks following surgery or trauma, history of estrogen-associated and "sine causa" superficial phlebitis, deep venous thrombophlebitis or other significant VTE (pulmonary embolism, stroke, etc.);
* use of tamoxifen, raloxifene or other SERMs within the last 4 weeks;
* anticoagulant therapy in progress (heparin or dicoumarol);
* active infections;
* severe psychiatric disorders or inability to comply to the protocol procedures; any other factor that at the investigator's discretion contraindicates the use of either tamoxifen or HRT.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01579734
Study Brief:
Protocol Section:
NCT01579734