Characterisation of ovulation inhibition and effects on metabolic parameters and haemostatic system of multiple administrations of a fixed-dose combination product containing 0.02 mg ethinylestradiol and 2 mg dienogest (24+4) in a multiple administration, comparative parallel-group trial vs. a marketed product containing 0.02 mg ethinylestradiol and 0.10 mg levonorgestrel with healthy females of childbearing potential
Phase 2
Completed
- Conditions
- inhibition of ovulationhormonal contraception
- Registration Number
- NL-OMON37701
- Lead Sponsor
- Zentiva k.s.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Healhy female subjects aged 18-35
Exclusion Criteria
Clinically significant abnormalities at screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>descriptive characterisation of the influence of Test or Reference on ovarian<br /><br>activity determined by means of maximum follicular diameter and Hoogland score</p><br>
- Secondary Outcome Measures
Name Time Method <p>descriptive characterisation of the effect of Test or Reference on endometrial<br /><br>thickness, cervical mucus as well as on the pituitary and ovarian hormones the<br /><br>latter determined via follicle stimulating hormone (FSH), luteinising hormone<br /><br>(LH), estradiol (E2) and progesterone (P)<br /><br><br /><br>descriptive characterisation of effect of Test or Reference on sex hormone<br /><br>binding globulin (SHBG) and corticosteroid binding globulin (CBG) levels,<br /><br>C-reactive protein, lipid profile as well as haemostatic and carbohydrate<br /><br>parameters<br /><br><br /><br>descriptive characterisation of bleeding pattern<br /><br><br /><br>descriptive characterisation of return of ovulation<br /><br><br /><br>descriptive characterisation of overall safety and tolerability in the study<br /><br>population.</p><br>