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 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT06800092
Eligibility Criteria:
Inclusion Criteria:
* Female
* Ages 30 - 50 years
* Self-reported menses occurrence within past 12 months
* Diagnosis of ER+/HER2- breast cancer
* Willing and able to comply with study procedures
* Willing and able to provide consent
Exclusion Criteria:
* Untreated thyroid disorder
* Untreated diabetes
* BMI \>30
* Current treatment with metformin
* Diagnosed neuromuscular disease
* Diagnosed neurovascular disease
* Prior history of cognitive impairment
* Prior history of chemotherapy treatment
* HIV, Hepatitis B or Hepatitis C
* Systolic blood pressure \<90 or \>170, diastolic blood pressure \<50 or \>110 after repeated evaluation with proper cuff. This range is the acceptable range stated in the prescribing information for sildenafil (\>90/50 and \<170/110)
* Use of alpha blockers in the past 2 weeks
* Use of PDE5 inhibitors in the past 2 weeks
* Use of nitrates
* Subjects with MRI incompatible devices
* Subjects with severe claustrophobia
* Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
50 Years
Study:
NCT06800092
Study Brief:
Protocol Section:
NCT06800092