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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007308-27 | EudraCT Number |
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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400 healthy women needed contraception will be asked to participate in this study. Half will be given EVRA, half will be given FC Patch low. They will be expected to apply the patches for 21 days of their cycle, for 7 cycles in total. The study will compare the patterns of menstrual bleeding on these two treatments, plus how effective they are at preventing pregnancy, general safety, and their acceptability to the participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016) | Drug | 0.55mg ethinylestradiol and 2.1mg gestodene |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding Patterns and cycle control | 7 cycles (each consisting of 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Contraceptive efficacy | 7 cycles (each consisting of 28 days) + follow up period of 14 days | |
| Adverse Event Collection | 7 cycles (each consisting of 28 days) | |
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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 |
|---|---|---|---|---|---|---|
| Mödling | Lower Austria | 2340 | Austria | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25453582 | Derived | Gruber D, Skrivanek A, Serrani M, Lanius V, Merz M. A comparison of bleeding patterns and cycle control using two transdermal contraceptive systems: a multicenter, open-label, randomized study. Contraception. 2015 Feb;91(2):105-12. doi: 10.1016/j.contraception.2014.10.003. Epub 2014 Oct 13. |
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| Norelgestromin/Ethinylestradiol (EVRA) | Drug | 0.6mg ethinylestradiol and 6mg norelgestromin |
|
| Population pharmacokinetics |
| 7 cycles (each consisting of 28 days) |
| Compliance to treatment | 7 cycles (each consisting of 28 days) |
| Subjective assessment of treatment | 7 cycles (each consisting of 28 days) |
| Wiener Neustadt |
| Lower Austria |
| 2700 |
| Austria |
| Graz | Styria | 8036 | Austria |
| Wörgl | Tyrol | 6300 | Austria |
| Bregenz | Vorarlberg | 6900 | Austria |
| Graz | 8010 | Austria |
| Innsbruck | 6020 | Austria |
| Vienna | 1050 | Austria |
| Vienna | 1090 | Austria |
| Zeltweg | 8740 | Austria |
| Brno | 602 00 | Czechia |
| České Budějovice | 37001 | Czechia |
| Hradec Králové | 500 02 | Czechia |
| Olomouc | 77900 | Czechia |
| Písek | 39701 | Czechia |
| Prague | 109 00 | Czechia |
| Prague | 120 00 | Czechia |
| Prague | 13000 | Czechia |
| Prague | 170 00 | Czechia |
| De Bilt | 3731 DN | Netherlands |
| Den Helder | 1782 GZ | Netherlands |
| Heerlen | 6401 MB | Netherlands |
| Nijmegen | 6525 EC | Netherlands |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| C033273 | Gestodene |
| C449219 | norelgestromin |
| C511292 | Ortho Evra |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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