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; - Women in need for contraception and willing to use an OC for 12 months (13 cycles); - At least 18 but not older than 50 years of age at the time of screening; - Body mass index =17 and =35; - 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: - 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; known predisposition for venous or arterial thrombosis, with or without hereditary involvement (e.g. Activated Protein C (APC) resistance; hyperhomocysteinaemia; deficiencies in ATIII, protein C, protein S; 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. - In accordance with the SmPC/Package Insert of DRSP-EE, additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predipose to hyperkalemia): • Renal insufficiency; • Hepatic dysfunction; • Adrenal insufficiency. - An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia (CIN), SIL, carcinoma in situ, invasive carcinoma) at screening; - Clinically relevant abnormal laboratory result at screening as judged by the investigator; - Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months 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, sex steroids (other than pre- and posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John’s Wort); - Admin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the NOMAC-E2 COC in a large group of women aged 18-50 years. ;Secondary Objective: - To evaluate the effect of the NOMAC-E2 COC on satisfaction and health related quality of life, libido, acne, menstrual symptoms, and body weight; - To explore the aforementioned characteristics of the NOMAC-E2 COC in comparison with the DRSP-EE COC. ;Primary end point(s): Pearl Index (PI), i.e. the number of pregnancies per 100 woman years of exposure for the restricted ITT analysis set; Vaginal bleeding (most relevant parameters: breakthrough bleeding/spotting and absence of withdrawal bleeding) | — |
Countries
Belgium, Czech Republic, Denmark, Finland, Germany, Hungary, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed