Trial Condition(s):

Contraception

Relative bioavailability, transdermally administered EE and GSD, 3 applications sites

Bayer Identifier:

91608

ClinicalTrials.gov Identifier:

NCT01083264

EudraCT Number:

2009-011151-52

Study Completed

Trial Purpose

Influence of different application sites on the blood levels after administration of a fertility control patch

Inclusion Criteria
- Healthy female subjects
 - Age 18-45 years
 - Body mass index (BMI) 18-30kg/m²
 - At least 3 months since delivery, abortion, or lactation before the first screening examination
 - Ability to understand and follow study-related instructions
 - Willingness to accept the synchronizing cycle and to use non-hormonal methods of contraception after starting the synchronizing cycle and during the treatment periods
Exclusion Criteria
- Contra-indications for use of combined (estrogen/progestin) contraceptives (e.g. history of venous/arterial disease, liver disorders, migraine)
 - Skin diseases with suspected alteration of dermal resorption and /or increased risk for dermal intolerance
 - Regular use of medicines other than contraceptives
 - Smokers (at the age of 31 to 45 years)
 - Clinically relevant findings (e.g. blood pressure, physical and gynecological examination, laboratory examination)

Trial Summary

Enrollment Goal
43
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Bayer Pharma AG

Berlin, Germany, 13353

Status
Completed
 

Trial Design