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 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT07061093
Eligibility Criteria:
Inclusion Criteria:
* Sexually active women, at risk for pregnancy and willing to use a contraceptive for at least 4 cycles
* Women with regular menstrual cycles with an intermenstrul period between 21 and 35 days
* An age between 18 and 50 years at time of screening
* Body mass index ≥18 and ≤30;
* Good physical and mental health;
* Choose either no hormonal contraception or one of the specific contraceptives under investigation
* Willing to give informed consent in writing
Exclusion Criteria:
* Contraindications for contraceptive steroids:
* 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;
* Precence 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 risck factor(s) for venous or arterial thrombosis (to be judged by the (sub)-investigator).
e.g. increasing age; smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age); a positive family history (i.e. venous or arterial thromboembolism ever in a sibling or parent at an age\< 40 years o); obesity (body mass index over 30 kg/m2); dyslipoproteinaemia; hypertension, migraine, valvular heart disease, atrial fibrillation; prolonged immobilization, major surgery any surgery to the legs, or major trauma (until two weeks after full remobilization); systemic lupus erythematosus; haemolytic uraemic syndrome; chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis); sickle cell disease;
* Severe dyslipoproteinemia
* Blood pressure above 140/90 mmHg
* Known hereditary or acquired predisposition for venous or arterial thrombosis, such as APC resistance, antithrombin-lll-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);
* Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia;
* Presence or history of severe hepatic disease as long as liver function values have not returned to normal;
* Presence or history of liver tumors (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 of the investigational product
* An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia (CIN), SIL, carcinoma in situ, invasive carcinoma) at the screening evaluation
* Clinically relevant abnormal laboratory data as judged by the investigator;
* Post-partum (6 months from delivery)
* Breastfeeding or 2 months from breastfeeding ending
* Present use or use in the last 2 months of the following drugs: phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and post-treatment contraceptive method) and herbal remedies containing Hipericum perforatum (St John's Wort);
* Administration of any other investigational drugs and/or participation in other clinical trial in the last 2 months.
* Present use of any oral contraceptive.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07061093
Study Brief:
Protocol Section:
NCT07061093