Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa
NCT ID: NCT00280657
Last Updated: 2023-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1326 participants
INTERVENTIONAL
2004-03-10
2005-05-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Valette
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
Arm 2
Diane
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
Arm 3
Placebo
2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
Interventions
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Valette
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
Diane
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
2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
45 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Chomutov, , Czechia
Čáslav, , Czechia
Kutná Hora, , Czechia
Louny, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Prague, , Czechia
Slaný, , Czechia
Svitavy, , Czechia
Ústí nad Labem, , Czechia
Grudziądz, , Poland
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Korolyov, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moskva, , Russia
Moskva, , Russia
Petrozavodsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Banská Bystrica, , Slovakia
Bratislava, , Slovakia
Kosice-Saca, , Slovakia
Košice, , Slovakia
Nitra, , Slovakia
Alchevs'k, , Ukraine
Chernivtsi, , Ukraine
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Luhansk, , Ukraine
Lviv, , Ukraine
Makiivka, , Ukraine
Odesa, , Ukraine
Poltava, , Ukraine
Rivne, , Ukraine
Simferopol, , Ukraine
Ternopil, , Ukraine
Uzhhorod, , Ukraine
Zaporizhzhia, , Ukraine
Countries
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Other Identifiers
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307760
Identifier Type: -
Identifier Source: secondary_id
91299
Identifier Type: -
Identifier Source: org_study_id
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