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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT00898560
Eligibility Criteria:
Inclusion Criteria:
* Pre-menopausal female subjects
* Age 18-40 years, inclusive
* Body mass index (BMI) 19-30 kg/m2, inclusive
* Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG
* Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
* Negative urine pregnancy test at screening and admission to each treatment period.
* Using one of the following methods of contraception: double barrier or intrauterine device
Exclusion Criteria:
* Subjects who have any contra-indication to the use of oral contraceptives
* History or presence of clinically relevant diseases, disorders or surgical history
* History of alcoholism or drug abuse
* Have used medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00898560
Study Brief:
Protocol Section:
NCT00898560