EUCTR2012-000041-12-NL
Active, not recruiting
Not Applicable
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 - Ovulation inhibition study with ethinylestradiol 0.02 mg/ dienogest 2 mg
Zentiva k.s. Prague0 sitesMarch 15, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Zentiva k.s. Prague
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •2\.age: 18 – 35 years inclusive; questioned at screening examination
- •3\.body\-mass index (BMI): \=30\.0 kg/m²; determined at screening examination
- •4\.good state of health
- •5\.both ovaries visible upon transvaginal ultrasonography; observed at screening examination
- •6\.ovulation observed by TVUS on or before day 27 (±1\) of the pre\-treatment cycle
- •7\.progesterone blood concentration \=16 nmol/L within 5 days after ovulation has been observed during pre\-treatment cycle
- •8\.non\-smoker, ex\-smoker for at least 6 months or moderate smoker (10 cigarettes or 2 cigars or 2 pipes per day) aged \=30 years; questioned at screening examination
- •9\.written informed consent, after having been informed about benefits and potential risks of the clinical trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •1\.existing diseases or pathological findings of uterus and/or ovaries which might interfere with the efficacy, safety or tolerability of the IMPs
- •2\.existing cardiac or haematological diseases or related pathological findings which might interfere with the efficacy, safety or tolerability of the IMPs
- •3\.existing hepatic and/or renal diseases or related pathological findings which might interfere with the efficacy, safety or tolerability of the IMPs
- •4\.existing gastrointestinal diseases or related pathological findings which might interfere with the absorption, efficacy, safety or tolerability of the IMPs
- •5\.history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- •6\.known allergic reactions or intolerances to the active ingredients used or to constituents of the pharmaceutical preparations
- •7\.subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
- •8\.severe and/or uncontrolled hypertension
- •9\.systolic blood pressure \>140mmHg
- •10\.diastolic blood pressure \>90mmHg
Outcomes
Primary Outcomes
Not specified
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