Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011151-52 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Influence of different application sites on the blood levels after administration of a fertility control patch
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gestodene/EE Patch (BAY86-5016) | Drug | Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: buttocks |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-168) for EE and Gestodene during week 4 of each treatment period | Week 4 of each treatment period ( 3 periods) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of EE and GSD: Cmax, Cmin, Cav, tmax, t1/2 obtained during week 4, Ctrough obtained at the end of each week | Week 1-5 of each treatment period | |
| Adverse Events | Week 1-5 of each treatment period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | State of Berlin | 13353 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gestodene/EE Patch (BAY86-5016) | Drug | Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: arm |
|
| Gestodene/EE Patch (BAY86-5016) | Drug | Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: abdomen |
|