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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,326
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
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
2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
Change in lesions
Time frame: 6 months
ISGA
Time frame: 6 months
Parameters of safety and tolerability
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Chomutov, Czechia
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Čáslav, Czechia
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Kutná Hora, Czechia
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Louny, Czechia
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Olomouc, Czechia
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Prague, Czechia
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Prague, Czechia
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Slaný, Czechia
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Svitavy, Czechia
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Ústí nad Labem, Czechia
...and 52 more locations