A Randomized, Open-Label, Comparative, Multicenter Trial to Compare the Effects on Metabolic Parameters of Two NOMAC-E2 Batches (Pivotal Phase III and Commercial Batch) and a Monophasic COC Containing 150 µg LNG and 30 µg EE (Protocol No. P06447)
- Conditions
- Hormonal oral contraception in healthy women
- Registration Number
- EUCTR2009-017288-40-NL
- Lead Sponsor
- Schering-Plough Research Institute, a Division of Schering Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
1. Each subject must be female and in good physical and mental health;
2. Each subject must be >=18 to <=50 years of age at screening;
3. Each subject must have a body mass index >=17 and <=29 kg/m2.
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
1. Any contraindication for contraceptive steroids;
2. An abnormal cervical smear (ie, dysplasia, cervical intraepithelial neoplasia (CIN), squamous intraepithelial lesion (SIL), carcinoma in situ, invasive carcinoma) at screening or documentation of an abnormal smear performed within 6 months prior to screening;
3. 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 of local dermatological use);
4. Present use or use within 2 months prior to starting trial medication of hepatic-enzyme inducing medications that may affect the bioavailability of sex steroids, lipid-lowering drugs, or anticoagulants.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effects on the APC - (Activated Protein C) resistance ratio (ETP -[endogenous thrombin potential] based) between the pivotal Phase III NOMAC-E2 (nomegestrol acetate - 17ß-estradiol) batch and a commercial NOMAC-E2 batch.;Secondary Objective: •To compare the effects on all other metabolic parameters between the pivotal Phase III NOMAC-E2 batch and a commercial NOMAC-E2 batch.<br>•To compare the effects on metabolic parameters between both NOMAC-E2 batches and a monophasic COC (combined oral contraceptive) containing 150 µg LNG (levonorgestrel) and 30 µg EE (ethinylestradiol);<br>•To evaluate general safety.<br>;Primary end point(s): The comparison of the effects on the APC-resistance ratio (ETP-based) (APCrr) between the pivotal Phase III NOMAC-E2 batch and the commercial NOMAC-E2 batch at the Cycle 3 visit for the AST group will be considered the primary outcome of the trial.<br>
- Secondary Outcome Measures
Name Time Method