EUCTR2009-009177-10-DE
Active, not recruiting
Not Applicable
Multicenter, open-label, randomized study to evaluate inhibition of ovulation of two transdermal patch formulations containing 0.55 mg ethinylestradiol and either 1.05 or 2.1 mg gestodene in healthy young female volunteers over a period of 3 treatment cycles - Inhibition of ovulation and pharmacokinetics of transdermal EE and GSD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- The trial will be performed in healthy female volunteers. The intended indication is femal contraception.
- Sponsor
- Bayer HealthCare AG
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent prior to study participation and confirmation of the volunteer’s health insurance coverage
- •Healthy female volunteer
- •Age: 18 – 35 years (inclusive) at the first screening examination (smokers not older than 30 years, inclusive)
- •Body mass index (BMI): 18 \= BMI \< \= 30 kg/m²
- •At least 3 months since delivery, abortion, or lactation before the screening visit
- •Willingness to use non\-hormonal methods of contraception during the entire study
- •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
Exclusion Criteria
- •Contraindications for use of a combined (estrogen/progesteron) contraception (e.g. history of venous/arterial thromembolic disease)
- •regular intake of medication other than OCs
- •Clinical relevant findings (heart rate, blood pressure, physical, gynecological examination, laboratory examination)
- •Anovulatory pre\-treatment cycle
- •Skin diseases with suspected alteration of dermal resorption and/or increased risk for dermal intolerance (e.g. psoriasis, neurodermitis, urticaria)
- •Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
Outcomes
Primary Outcomes
Not specified
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