Multi-center, open-label, randomized, parallel-group comparison of cycle control, bleeding pattern, lipid and carbohydrate metabolism of the transdermal contraceptive patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen vs. a comparator patch EVRA® (0.6 mg ethinylestradiol and 6 mg norelgestromin) in a 21-day regimen for 7 cycles in 400 women - Transdermal contraceptive patch: EU cycle control study (vs. EVRA)
- Conditions
- Prevention of pregnancyMedDRA version: 9.1Level: LLTClassification code 10060346Term: Transdermal contraception
- Registration Number
- EUCTR2008-007308-27-NL
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 400
1.Signed and dated informed consent
2.Healthy woman requesting contraception
3.Age: 18 – 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent
4.Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
5.History of regular cyclic menstrual periods
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Pregnancy or lactation, obesity (BMI > 30), hypersensitivity to any ingredient of the study drug, significant skin reaction to transdermal preparations, any diseases/conditions that can compromise the functions of the body system (resulting in altered absorption/ accumulation/ metabolism/ excretion of the study drug), any diseases/ conditions that may worsen under hormonal treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to investigate the bleeding pattern and cycle control parameters of the transdermal contraceptive patch FC Patch Low (material no. 80876395 containing 0.55 mg EE and 2.1 mg GSD) in comparison to the EVRA patch (containing 0.6 mg EE and 6 mg NGMN).;Secondary Objective: The secondary objectives are the contraceptive efficacy, safety profile (including lipid/carbohydrate metabolism), and population pharmacokinetics of FC Patch Low in comparison to the EVRA patch.<br><br>Additionally, compliance and subjective assessment of the treatment will be evaluated as secondary objectives.;Primary end point(s): Cycle control parameters and bleeding pattern indices
- Secondary Outcome Measures
Name Time Method