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The purpose of this study is to look into the effectiveness of a new investigational medication applied as a transdermal patch. The patch is applied on the skin with study medication that is absorbed through the skin suppressing ovarian activity and therefore preventing an egg from leaving an ovary (ovulation). The study will look into the study drug's safety and how well it is tolerated and its absorption, breakdown and elimination in the body. It describes how the body affects a specific drug after administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gestodene/EE Patch | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gestodene/EE Patch (BAY86-5016) | Drug | 7 day patch containing 0.55 mg ethinyl estradiol and 2.1 gestodene in a 21 day regimen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Suppression of ovulatory activity proved by progesterone and estradiol concentrations | Estradiol levels > 100pmol/L indicate some ovarian activity and progesterone levels > 5nmol/L in subjects with estradiol levels > 100pmol/L reflect ovulation or luteinized unruptured follicles. | Treatment day 29 to day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration, AUC (area under curve) of Gestodene | Multiple time points up to treatment day 84 | |
| Serum concentration, AUC (area under curve) of ethinyl estradiol | Multiple time points up to treatment day 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irkutsk | 664003 | Russia | ||||
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| Serum concentration, AUC (area under curve) of Sexual hormone binding globulin | Multiple time points up to treatment day 84 |
| Number of patients with adverse events | Up to 84 days |
| Number of patients with abnormal safety laboratory | Up to 84 days |
| Time course of follicle-stimulating hormone | Serum concentration of follicle-stimulating hormone (FSH) | Day 27 of pretreatment cycle to treatment day 83 |
| Time course of luteinizing hormone | Serum concentration of luteinizing hormone (LH) | Day 27 of pretreatment cycle to treatment day 83 |
| Krasnodar |
| 350063 |
| Russia |
| Moscow | 115280 | Russia |
| Saint Petersburg | 197374 | Russia |
| Saint Petersburg | 199034 | Russia |
| Smolensk | 214019 | Russia |
| Kiev | 04050 | Ukraine |
| Zaporizhzhya | 69068 | Ukraine |