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 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT07264257
Eligibility Criteria:
Inclusion Criteria:
* Women aged 50-65 years
* Postmenopausal: Women who are postmenopausal will have not had a period in the last 12 months, have FSH\>30 IU/L, and estradiol (E2) \<50 pg/ml.
* Nonsmokers
* Not taking hormone therapy, SSRIs, phytoestrogens, SERMS, or antiestrogen medications and will be at least one year without such treatment
* Physically healthy
* No cardiovascular disease other than mild hypertension. Subjects will also not have current untreated or unremitted Axis I or II psychiatric or cognitive disorders (see screening below).
* IQ in the normal range \>80
* Normal neuropsychological test performance
Exclusion Criteria:
* MCI or dementia - Montreal Cognitive Assessment \<26, Mattis Dementia Rating Scale \<130, and Global Deterioration Scale \>2
* History of cancer treatment with cytotoxic and/or ongoing (current) maintenance targeted chemotherapy
* Blood pressure \> 160/100 (untreated)
* Untreated thyroid disease
* Significant cardiovascular disease
* Asthma or COPD
* Active peptic ulcer
* Hyperthyroidism
* Epilepsy
* Current untreated or unremitted Axis I psychiatric disorders
* Use of medications on the Prohibited medications (see list)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
65 Years
Study:
NCT07264257
Study Brief:
Protocol Section:
NCT07264257