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 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT00998257
Eligibility Criteria:
Inclusion Criteria:
* Healthy female subjects
* requesting contraception
* suggesting PMDD by Physician who are also requesting contraception
* with acne who are also requesting contraception
* Age: 18 - 50 years
* Women who is prescribed YAZ first, during study period
Exclusion Criteria:
* Women who are contraindicated based on the label of YAZ
* Presence or a history of venous or arterial thrombotic/ thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident
* Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris)
* History of migraine with focal neurological symptoms
* Diabetes mellitus with vascular involvement
* The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication
* Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
* Presence or history of severe hepatic disease as long as liver function values have not returned to normal
* Severe renal insufficiency or acute renal failure
* Presence or history of liver tumours (benign or malignant)
* Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts)
* Undiagnosed vaginal bleeding
* Known or suspected pregnancy
* Hypersensitivity to the active substances or to any of the excipients
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00998257
Study Brief:
Protocol Section:
NCT00998257