Hormonal oral contraception in healthy women
Conditions
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Sexually active women, at risk for pregnancy and not planning to use condoms during trial medication use; • Women in need for contraception and willing to use an OC for 6 months (6 cycles); • At least 18 but not older than 50 years of age at the time of screening; • Body mass index =17 and =29 kg/m2; • Good physical and mental health; • Willing to give informed consent in writing. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Present use or use within 2 months prior to screening of any other hormonal treatment including sex hormones (other than contraceptives), insulin, thyroid and corticosteroid hormones (with the exception for local dermatological use); • 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; - 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 (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 a relatively early age); 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; - Severe hypertension; - Hereditary or acquired predisposition for venous or arterial thrombosis, such as APC resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipidantibodies (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 or comparator product. • Presence or history (within 1 year before screening) of alcohol or drug abuse as judged by the (sub)investigator; • An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia (CIN), SIL, carcinoma in situ, invasive carcinoma) 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 (sub)investigator; • Use of an injectable hormonal method of contraception prior to screening; within 6 months of an injection with a 3-month duration, within 4 months to screening of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration; • Before spontaneous menstruation has occurred following a delivery or abortion; • Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication; • Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, lipid-l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the effects on hemostasis of NOMAC-E2 compared to LNG-EE. • To evaluate the effects on lipids and carbohydrate metabolism of NOMAC-E2 compared to LNG-EE. • To evaluate the effects on adrenal and thyroid function of NOMAC-E2 compared to LNG-EE. ;Secondary Objective: • To collect data on contraceptive efficacy, cycle control and safety of NOMAC-E2 compared to LNG-EE. • To evaluate the effects on androgen levels of NOMAC-E2 compared to LNG-EE. ;Primary end point(s): Hemostatis parameters, lipids and carbohydrate metabolism parameters, adrenal and thyroid function parameters. | — |
Countries
Finland
Outcome results
None listed