Relative Bioavailability, Transdermally Administered EE and GSD, 3 Applications Sites

Bayer

Status and phase

Completed

Phase 1

Conditions

Contraception

Treatments

Drug: Gestodene/EE Patch (BAY86-5016)

Study type

Interventional

Funder types

Industry

Identifiers

2009-011151-52 (EudraCT Number)

91608

Details and patient eligibility

About

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

Enrollment

43 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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)