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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT05672667
Eligibility Criteria:
Inclusion Criteria:
* Male or female \> 18 and \< 75 years of age, Body Mass Index (BMI) \<40.
* Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical status 1 or 2.
* For healthy volunteers, normal blood pressure (systolic 100-140 mmHg; diastolic 60-90 mmHg) resting heart rate 45-90 beats per minute) without medication. For those with hypertension, blood pressure controlled with anti-hypertensive medication and with a resting heart rate 45-100 beats per minute.
* Female subjects of child-bearing potential and those \< 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.
Exclusion Criteria:
* Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
* Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
* Women who are pregnant (positive result for urine pregnancy test at visit 1), women who are currently nursing or lactating, women that have been pregnant within 2 years
* Subjects with neuropathy, chronic pain (being treated on a daily basis), diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
* Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval.
* Subjects with past or current history of hyponatremia or at risk for hyponatremia; anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, Selective serotonin reuptake inhibitors (SSRI's) , Monoamine oxidase inhibitors (MAOI), or the recreational drug ecstasy.
* Subjects with a known latex allergy.
* History of chronic nasal obstruction or local pathology in nostril pathway which, in the opinion of the investigator, would prevent appropriate nasal administration of the study drug.
* Use of over the counter nasal products (ie. Saline spray, Neti-Pot, etc.) or intranasal corticosteroid medications during the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05672667
Study Brief:
Protocol Section:
NCT05672667