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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT02127593
Eligibility Criteria:
Inclusion Criteria:
* Participants must be either surgically sterile or of child-bearing potential and be practicing an effective non-hormonal method of birth control (for example, copper intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study
* If a woman of child-bearing potential, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day -1 of the each treatment period
* Participants must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after the last dose
* Body mass index (BMI: weight \[kilogram {kg}\]/height\^2 \[meter {m}\]\^2) between 18.5 and 30 kg/m\^2 (inclusive), and body weight not less than 50 kilogram (kg) or higher than 90 kg (198 pounds)
* Participant must be a non-smoker
Exclusion Criteria:
* Participants have a levonorgestrel implant (for example, Norplant) in place or removed within the 30 days before admission to the study site
* Contraindications to combined hormonal contraceptives
* Participants who received medroxyprogesterone injection (for example, Depo Provera) within 6 months of admission to the study
* Use of any other hormonal contraceptive within 30 days of admission to the study site
* Participants with abnormal papanicolaou (Pap) smear or CytoRich test
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02127593
Study Brief:
Protocol Section:
NCT02127593