Hormonal oral contraception in healthy women
Conditions
Interventions
Product Name: NOMAC-E2 batch CZ189
Product Code: Org 10486-0 + Org 2317 (SCH 900121)
Pharmaceutical Form: Tablet
INN or Proposed INN: NOMEGESTROL ACETATE
CAS Number: 58652-20-3
Current Sponsor code: O
Sponsors
Schering-Plough Research Institute, a Division of Schering Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Each subject must be female and in good physical and mental health; 2. Each subject must be >=18 to =17 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. •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); •To evaluate general safety. ;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. | — |
Countries
Netherlands
Outcome results
None listed