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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT01714193
Eligibility Criteria:
Inclusion Criteria:
* Volunteer must have a body mass index (weight \[kg\]/height \[m2\]) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
* Volunteer must be a non-smoker (has not used tobacco or nicotine products in 6 months)
Exclusion Criteria:
* History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
* History of, or presence of, disorders commonly accepted as contraindications to sex hormonal therapy and contraindications to therapy with combined oral contraceptives
* Volunteer has used, or is currently using, any hormonal contraceptive within 30 days of admission to the study center or has received Depo Provera (or other combined contraceptive injection or hormonal contraceptive implant) in the 6 months prior to screening
* Volunteer is breast-feeding
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01714193
Study Brief:
Protocol Section:
NCT01714193