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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT00511433
Eligibility Criteria:
Inclusion Criteria:
* Willing to use COC for at least 6 cycles.
* 18 - 35 years of age at screening.
* Body Mass Index (BMI) of \>/= 17 and \</= 35.
* Good physical and mental health.
* Willing to use condoms as the sole contraceptive method during screening cycle and 1 post-treatment cycle.
* Willing to give informed consent.
Exclusion Criteria:
* Contraindications for contraceptive steroids (general).
* Additional contraindications (renal, hepatic or adrenal insufficiency).
* Breastfeeding.
* Present use (or use within 2 months prior to start of the trial medication) of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex
steroids (other than pre- and post treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St. John's Wort).
* Administration of any other investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
* Abnormal cervical smear at screening, or documentation of an abnormal smear performed within 6 months before screening.
* Clinically relevant abnormal laboratory result at screening as judged by the investigator.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT00511433
Study Brief:
Protocol Section:
NCT00511433