EUCTR2010-021255-81-NL
Active, not recruiting
Not Applicable
Multicenter, open-label, randomized study to evaluate inhibition of ovulation during treatment with three transdermal patch formulations containing 0.55 mg ethinylestradiol (EE) and 2.10 mg gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in healthy young female volunteers over a period of 3 treatment cycles - Inhibition of ovulation and pharmacokinetic study of 3 transdermal EE and GSD formulations
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prevention of Pregnancy
- Sponsor
- Bayer HealthCare AG
- Enrollment
- 174
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Healthy female subject
- •2\.Age: 18 to 35 years (inclusive) at the first screening visit
- •3\.Body mass index (BMI): \= 18 kg/m²
- •4\.Ability to understand and follow study\-related instructions
- •5\.Willingness to use non\-hormonal methods of contraception during the entire study
- •6\.Signed informed consent before any study specific tests or procedures are done
- •7\.Confirmation of the subject’s health insurance coverage prior to the first screening examination
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\.Incompletely cured pre\-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- •2\.Known or suspected malignant tumors (including after treatment)
- •3\.Known or suspected benign tumors of the liver, pituitary and adrenal gland (including after treatment)
- •4\.Known or suspected liver disorders, including disturbances of bilirubin metabolism (e.g. Dubin\-Johnson and Rotor syndromes) and bile secretion/flow (cholestasis, also history of it)
- •5\.Conditions/diseases known to occur or deteriorate with both pregnancy and COC use.
- •6\.Presence or history of pancreatitis
- •7\.Presence or history of venous or arterial thrombotic/thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischaemic attack, angina pectoris) and conditions that could increase the risk to suffer from any of the above mentioned disorders, e.g. a family history indicating hereditary predisposition
- •8\.Diseases associated with adverse vascular events (e.g. diabetes mellitus, chronic inflammatory diseases like Crohn’s disease or colitis ulcerosa, severe disorders of lipid metabolism, sickle\-cell anemia)
- •9\.Severe renal insufficiency or acute renal failure
- •14\.Skin diseases with suspected alteration of dermal resorption and/or increased risk for dermal intolerance (e.g. psoriasis, neurodermitis, urticaria)
Outcomes
Primary Outcomes
Not specified
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