A randomized, open-label, comparative, multi-center trial to evaluate contraceptive efficacy, cycle control, safety and acceptability of a monophasic combined oral contraceptive (COC) containing 2.5 mg nomegestrol acetate (NOMAC) and 1.5 mg estradiol (E2), compared to a monophasic COC containing 3 mg drospirenone (DRSP) and 30 µg ethinyl estradiol (EE). - Samba
- Conditions
- Hormonal oral contraception in healthy women
- Registration Number
- EUCTR2005-005304-16-GB
- Lead Sponsor
- V Organon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 2080
- 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
- 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 d
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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.<br> ;<br> Secondary Objective: - To evaluate the effect of the NOMAC-E2 COC on satisfaction and health related<br> quality of life, libido, acne, menstrual symptoms, and body weight;<br> - To explore the aforementioned characteristics of the NOMAC-E2 COC in comparison<br> with the DRSP-EE COC.<br> ;<br> 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;<br> Vaginal bleeding (most relevant parameters: breakthrough bleeding/spotting and absence of withdrawal bleeding)<br>
- Secondary Outcome Measures
Name Time Method