Contraception
Conditions
Keywords
Fertility control, Contraception
Brief summary
The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.
Interventions
DRUGEthinylestradiol/Gestogene (BAY86-5016)
7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Requiring contraception * Normal cervical smear * Smokers not older than 30 years * History of regular cyclic menstrual periods
Exclusion criteria
* Pregnancy or lactation * Obesity (BMI\> 30 kg/m2) * Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape * Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic) * Use of other contraceptive methods than study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect on the endometrium at cycle 13 | 13 treatment cycles (each consisting of 28 days) |
Secondary
| Measure | Time frame |
|---|---|
| Cervical smear | 13 treatment cycles (each consisting of 28 days) |
| Adverse events | 13 treatment cycles (each consisting of 28 days) |
| Cycle control | 13 treatment cycles (each consisting of 28 days) |
| Safety laboratory | 13 treatment cycles (each consisting of 28 days) |
| Occurence of pregnancy | 13 treatment cycles (each consisting of 28 days) |
Other
| Measure | Time frame |
|---|---|
| Treatment compliance | 13 treatment cycles (each consisting of 28 days) |
| Subjective assessment of satisfaction with the treatment | 13 treatment cycles (each consisting of 28 days) |
Countries
Germany
Outcome results
None listed