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:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT00729404
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent,
* BMI: 18 - 30 kg/m²,
* Healthy female volunteers,
* Age 18-35 years (smoker not older than 30 years, inclusive),
* Ovulatory pre-treatment cycle, at least 3 month since delivery,
* Abortion or lactation before the first screening examination,
* Willingness to use non-hormonal methods of contraception during entire study
Exclusion Criteria:
* Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/arterial thromboembolic disease
* Regular intake of medication other than OCs
* Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination)
* Anovulatory pre-treatment cycle
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT00729404
Study Brief:
Protocol Section:
NCT00729404