A randomized, open-label, comparative, multi-center trial to evaluate the effects on hemostasis, lipids and carbohydrate metabolism, and on adrenal and thyroid function of a monophasic COC containing 2.5 mg NOMAC and 1.5 mg E2, compared to a monophasic COC containing 150 µg LNG and 30 µg EE
- Conditions
- Hormonal oral contraception in healthy women
- Registration Number
- EUCTR2006-000676-33-FI
- Lead Sponsor
- V Organon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To evaluate the effects on hemostasis of NOMAC-E2 compared to LNG-EE.<br>• To evaluate the effects on lipids and carbohydrate metabolism of NOMAC-E2 compared to LNG-EE.<br>• To evaluate the effects on adrenal and thyroid function of NOMAC-E2 compared to LNG-EE.<br>;Secondary Objective: • To collect data on contraceptive efficacy, cycle control and safety of NOMAC-E2 compared to LNG-EE.<br>• To evaluate the effects on androgen levels of NOMAC-E2 compared to LNG-EE.<br>;Primary end point(s): Hemostatis parameters, lipids and carbohydrate metabolism parameters, adrenal and thyroid function parameters.
- Secondary Outcome Measures
Name Time Method