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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT01798394
Eligibility Criteria:
Inclusion Criteria:
* Woman
* 18-35 years old
* Zero CPD for past 4 weeks
* 5 or more CPD for at least 6 out of past 12 months
* Motivated to remain abstinent (7 or higher out of 10)
* Stable physical/mental health
* Established prenatal care
* Stable physical/mental health
* Willing to take Progesterone
* Willing to use double-barrier protection if sexually active
* English fluency
* Able to provide informed consent
Exclusion Criteria:
* Psychotropic medications
* Illicit drugs
* Other types of tobacco, NRT, smoking cessation medications
* Pregnancy complications (Diabetes, Anomaly, Fetal growth restriction, HTN, Hx of \>2 miscarriages)
* Current use of: Finasteroid (propecia), Efavirenz, Red Clover, Ketoconazole, CYP3A4 Inhibitors
* History of: Thrombophelitis, Deep vein thrombosis, Pulmonary embolus, Clotting disorder, Bleeding disorder, Heart disease, Diabetes, Stroke, Peanut allergy, Liver dysfunction, Hypersensitivity to progesterone
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT01798394
Study Brief:
Protocol Section:
NCT01798394