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 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT06315205
Eligibility Criteria:
Inclusion Criteria:
* Healthy post-menopausal women.
* Capable of providing informed consent.
* Weight of ≥50 kg and a BMI ≥19 and ≤39 kg/m2.
* Subjects should be able to communicate with clinic staff.
Exclusion Criteria:
* Subjects who have a history of allergy or hypersensitivity to letrozole or any of the inactive ingredients.
* Subjects who have a history of galactose intolerance, severe hereditary lactase deficiency glucose-galactose malabsorption.
* Subjects who have used estrogen or progesterone hormone replacement therapy, thyroid replacement therapy, oral contraceptives, androgens, luteinizing hormone (LH) releasing hormone analogs, prolactin inhibitors, or antiandrogens within prior to Screening.
* Subjects who have used: any medications including St. John's wort or any medications or products known to be potent or moderate inhibitors of CYP P450 3A4.
* Subjects who have been diagnosed with osteoporosis.
* Subjects who have an abnormality at Screening or prior to first dose that in the opinion of the investigator increases the risk of participating in the study.
* Subjects who have any clinically significant abnormal physical examination or laboratory safety findings at screening.
* Subjects who have relevant diseases or clinically significant abnormal relevant findings at Screening, as determined by medical history, physical examination, laboratory, ECG, DEXA, and breast and pelvic examination.
* Subjects who have history of any significant chronic disease.
* History of cancer within the past 5 years with the exception of non-melanoma skin cancer.
* Subjects who have a history of drug-dependence, and recent history of alcoholism or abuse of alcohol.
* Subjects who have received a drug in research or have participated in other clinical trials within 90 days, prior to dosing.
* Any other unspecified reason that, in the opinion of the investigator (or designee) or sponsor, makes the subject unsuitable for enrolment.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06315205
Study Brief:
Protocol Section:
NCT06315205