check_circleStudy Completed

Acne Vulgaris

Bayer Identifier:

91299

ClinicalTrials.gov Identifier:

NCT00280657

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study on safety and efficacy of an oral contraceptive in treating acne papulopustulosa

Trial purpose

The purpose of the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa.

Key Participants Requirements

Sex

Female

Age

16 - 45 Years
  • - Patients with mild to moderate facial papulopustular acne
  • - Contraindication against use of hormonal contraceptives

Trial summary

Enrollment Goal
1326
Trial Dates
March 2004 - May 2005
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Valette (Dienogest/EE30, BAY86-5038)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Usti nad Labem, 40010, Czechia
Completed
Praha, 10034, Czechia
Completed
Chomutov, 43012, Czechia
Completed
Lublin, 20319, Poland
Completed
Lodz, 90265, Poland
Completed
Poznan, 60631, Poland
Completed
Warszawa, 02722, Poland
Completed
Grudziadz, 86-300, Poland
Completed
St. Petersburg, 197183, Russian Federation
Completed
Sankt-Peterburg, 195067, Russian Federation
Completed
Moscow, 123423, Russian Federation
Completed
Moscow, 125009, Russian Federation
Completed
Moskva, 107076, Russian Federation
Completed
St. Petersburg, 190020, Russian Federation
Completed
Moscow, 121614, Russian Federation
Completed
St. Petersburg, 194044, Russian Federation
Completed
Moscow, 125047, Russian Federation
Completed
Moscow, 123182, Russian Federation
Completed
Kosice-Saca, 04015, Slovakia
Completed
Bratislava, 83331, Slovakia
Completed
Dnipropetrovsk, 49076, Ukraine
Completed
Kiev, 01032, Ukraine
Completed
Alchevsk, 94201, Ukraine
Completed
Kiev, 03035, Ukraine
Completed
Ternopil, 46006, Ukraine
Completed
Kiev, 01032, Ukraine
Completed
Odessa, 65006, Ukraine
Completed
Kharkiv, 61057, Ukraine
Completed
Donetsk, 83087, Ukraine
Completed
Makeevka, 86106, Ukraine
Completed
Caslav, 28601, Czechia
Completed
Kutna Hora, 28401, Czechia
Completed
Olomouc, 77900, Czechia
Completed
Slany, 274 01, Czechia
Completed
Svitavy, 56802, Czechia
Completed
Praha, 15500, Czechia
Completed
Louny, 44001, Czechia
Completed
Warszawa, 00710, Poland
Completed
Warszawa, 01684, Poland
Completed
Warszawa, 01456, Poland
Completed
Wroclaw, 50-353, Poland
Completed
Warszawa, 01456, Poland
Completed
St. Petersburg, 197198, Russian Federation
Completed
Moskva, 107076, Russian Federation
Completed
Petrozavodsk, 185910, Russian Federation
Completed
Moscow, 109004, Russian Federation
Completed
Lviv, 81130, Ukraine
Completed
Sankt-Peterburg, 194 291, Russian Federation
Completed
St. Petersburg, 192012, Russian Federation
Completed
Moskva, 121002, Russian Federation
Completed
Korolev, 141074, Russian Federation
Completed
St. Petersburg, 192102, Russian Federation
Completed
St. Petersburg, 194175, Russian Federation
Completed
Kosice, 04066, Slovakia
Completed
Banska Bystrica, 97401, Slovakia
Completed
Nitra, 94901, Slovakia
Completed
Uzhhorod, 88011, Ukraine
Completed
Ivano-Frankivsk, 76000, Ukraine
Completed
Chernivtsi, 58000, Ukraine
Completed
Poltava, 314039, Ukraine
Completed
Kyiv, 01021, Ukraine
Completed
Zaporizhzhia, 69063, Ukraine
Completed
Rivne, 33028, Ukraine
Completed
Simferopol, 95006, Ukraine
Completed
Lugansk, 91017, Ukraine

Primary Outcome

  • Change in lesions
    date_rangeTime Frame:
    6 months
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • ISGA
    date_rangeTime Frame:
    6 months
    enhanced_encryption
    Safety Issue:
    no
  • Parameters of safety and tolerability
    date_rangeTime Frame:
    6 months
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Multicenter, double-blind, double-dummy, randomized parallel group study to evaluate the safety and efficacy of SH D 00659 E for 6 treatment cycles in female patients with acne papulopustulosa in comparison to SH D 00659 G and placebo.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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