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| ID | Type | Description | Link |
|---|---|---|---|
| 307760 |
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The purpose of the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa.
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valette | Drug | 1 tablet 0.030 mg ethinylestradiol / 2 mg dienogest + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in lesions | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| ISGA | 6 months | |
| Parameters of safety and tolerability | 6 months |
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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 |
|---|---|---|---|---|---|---|
| Chomutov | 43012 | Czechia | ||||
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| Diane | Drug | 1 tablet 0.035 mg ethinylestradiol / 2 mg cyproterone acetate + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles |
|
| Placebo | Drug | 2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles |
|
| Čáslav |
| 28601 |
| Czechia |
| Kutná Hora | 28401 | Czechia |
| Louny | 44001 | Czechia |
| Olomouc | 77900 | Czechia |
| Prague | 10034 | Czechia |
| Prague | 15500 | Czechia |
| Slaný | 274 01 | Czechia |
| Svitavy | 56802 | Czechia |
| Ústí nad Labem | 40010 | Czechia |
| Grudziądz | 86-300 | Poland |
| Lodz | 90265 | Poland |
| Lublin | 20319 | Poland |
| Poznan | 60631 | Poland |
| Warsaw | 00710 | Poland |
| Warsaw | 01456 | Poland |
| Warsaw | 01684 | Poland |
| Warsaw | 02722 | Poland |
| Wroclaw | 50-353 | Poland |
| Korolyov | 141074 | Russia |
| Moscow | 109004 | Russia |
| Moscow | 121614 | Russia |
| Moscow | 123182 | Russia |
| Moscow | 123423 | Russia |
| Moscow | 125009 | Russia |
| Moscow | 125047 | Russia |
| Moskva | 107076 | Russia |
| Moskva | 121002 | Russia |
| Petrozavodsk | 185910 | Russia |
| Saint Petersburg | 190020 | Russia |
| Saint Petersburg | 192012 | Russia |
| Saint Petersburg | 192102 | Russia |
| Saint Petersburg | 194 291 | Russia |
| Saint Petersburg | 194044 | Russia |
| Saint Petersburg | 194175 | Russia |
| Saint Petersburg | 195067 | Russia |
| Saint Petersburg | 197183 | Russia |
| Saint Petersburg | 197198 | Russia |
| Banská Bystrica | 97401 | Slovakia |
| Bratislava | 83331 | Slovakia |
| Kosice-Saca | 04015 | Slovakia |
| Košice | 04066 | Slovakia |
| Nitra | 94901 | Slovakia |
| Alchevs'k | 94201 | Ukraine |
| Chernivtsi | 58000 | Ukraine |
| Dnipropetrovsk | 49076 | Ukraine |
| Donetsk | 83087 | Ukraine |
| Ivano-Frankivsk | 76000 | Ukraine |
| Kharkiv | 61057 | Ukraine |
| Kiev | 01032 | Ukraine |
| Kiev | 03035 | Ukraine |
| Kyiv | 01021 | Ukraine |
| Luhansk | 91017 | Ukraine |
| Lviv | 81130 | Ukraine |
| Makiyivka | 86106 | Ukraine |
| Odesa | 65006 | Ukraine |
| Poltava | 314039 | Ukraine |
| Rivne | 33028 | Ukraine |
| Simferopol | 95006 | Ukraine |
| Ternopil | 46006 | Ukraine |
| Uzhhorod | 88011 | Ukraine |
| Zaporizhzhia | 69063 | Ukraine |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D003534 | Cyproterone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
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