A randomized, open-label, comparative, multi-center trial to evaluate contraceptive efficacy, cycle control, safety and acceptability of a monophasic 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 g ethinyl estradiol EE . - Samba

Conditions: prevention of in treatment pregnancies
MedDRA version: 6.1Level: PTClassification code 10010808

Registration Number: EUCTR2005-005304-16-IT

Lead Sponsor: V Organon

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 2080

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 Oral Contraceptive 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 8805;17 and 8804;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

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 . - 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 , Squamous Intraepithelial Lesion 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 during 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 post treatment contraceptive method and herbal remedies containing Hypericum perforatum St John s Wort ; Administration of any other investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary 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: Secondary objectives To evaluate the effects 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): Contraceptive efficacy prevention of in treatment pregnancies Pearl Index

Secondary Outcome Measures