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 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT05901467
Eligibility Criteria:
Inclusion Criteria:
* No prescription medications that could interfere with hypothalamic reproductive function
* No illicit drug use
* No excessive alcohol consumption (more than 10 drinks/week)
* No history of an allergic medication reaction requiring emergency medical care
* Normal blood pressure reading (systolic blood pressure \< 140 mm Hg, diastolic \< 90 mm Hg)
* White blood cell, platelet counts, prolactin, and thyroid-stimulating hormone (TSH) between 90% of the lower limit and 110% of the upper limit of the reference range
* Normal hemoglobin
* Blood urea nitrogen (BUN), creatinine not elevated
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) within 3 times upper limit of normal
* Enrolled in the Partners HealthCare Biobank and genotypically characterized
* For women
* No oral contraceptives for at least 1 month
* No contraceptive implants for at least 3 months
* Not breastfeeding and not pregnant
* Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05901467
Study Brief:
Protocol Section:
NCT05901467