Back to resultsStudy on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Valette
Diane
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne papulopustulosa
Eligibility Criteria
Inclusion Criteria: Patients with mild to moderate facial papulopustular acne Exclusion Criteria: Contraindication against use of hormonal contraceptives
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Outcomes
Primary Outcome Measures
Change in lesions
Secondary Outcome Measures
ISGA
Parameters of safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00280657
Brief Title
Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2004 (Actual)
Primary Completion Date
May 21, 2005 (Actual)
Study Completion Date
May 21, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne papulopustulosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1326 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Title
Arm 3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Valette
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Diane
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
Primary Outcome Measure Information:
Title
Change in lesions
Time Frame
6 months
Secondary Outcome Measure Information:
Title
ISGA
Time Frame
6 months
Title
Parameters of safety and tolerability
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with mild to moderate facial papulopustular acne
Exclusion Criteria:
Contraindication against use of hormonal contraceptives
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Caslav
ZIP/Postal Code
28601
Country
Czechia
City
Chomutov
ZIP/Postal Code
43012
Country
Czechia
City
Kutna Hora
ZIP/Postal Code
28401
Country
Czechia
City
Louny
ZIP/Postal Code
44001
Country
Czechia
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
City
Praha
ZIP/Postal Code
10034
Country
Czechia
City
Praha
ZIP/Postal Code
15500
Country
Czechia
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
City
Svitavy
ZIP/Postal Code
56802
Country
Czechia
City
Usti nad Labem
ZIP/Postal Code
40010
Country
Czechia
City
Grudziadz
ZIP/Postal Code
86-300
Country
Poland
City
Lodz
ZIP/Postal Code
90265
Country
Poland
City
Lublin
ZIP/Postal Code
20319
Country
Poland
City
Poznan
ZIP/Postal Code
60631
Country
Poland
City
Warszawa
ZIP/Postal Code
00710
Country
Poland
City
Warszawa
ZIP/Postal Code
01456
Country
Poland
City
Warszawa
ZIP/Postal Code
01684
Country
Poland
City
Warszawa
ZIP/Postal Code
02722
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-353
Country
Poland
City
Korolev
ZIP/Postal Code
141074
Country
Russian Federation
City
Moscow
ZIP/Postal Code
109004
Country
Russian Federation
City
Moscow
ZIP/Postal Code
121614
Country
Russian Federation
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125009
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125047
Country
Russian Federation
City
Moskva
ZIP/Postal Code
107076
Country
Russian Federation
City
Moskva
ZIP/Postal Code
121002
Country
Russian Federation
City
Petrozavodsk
ZIP/Postal Code
185910
Country
Russian Federation
City
Sankt-Peterburg
ZIP/Postal Code
194 291
Country
Russian Federation
City
Sankt-Peterburg
ZIP/Postal Code
195067
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
190020
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
192012
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
192102
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194175
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197183
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197198
Country
Russian Federation
City
Banska Bystrica
ZIP/Postal Code
97401
Country
Slovakia
City
Bratislava
ZIP/Postal Code
83331
Country
Slovakia
City
Kosice-Saca
ZIP/Postal Code
04015
Country
Slovakia
City
Kosice
ZIP/Postal Code
04066
Country
Slovakia
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
City
Alchevsk
ZIP/Postal Code
94201
Country
Ukraine
City
Chernivtsi
ZIP/Postal Code
58000
Country
Ukraine
City
Dnipropetrovsk
ZIP/Postal Code
49076
Country
Ukraine
City
Donetsk
ZIP/Postal Code
83087
Country
Ukraine
City
Ivano-Frankivsk
ZIP/Postal Code
76000
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61057
Country
Ukraine
City
Kiev
ZIP/Postal Code
01032
Country
Ukraine
City
Kiev
ZIP/Postal Code
03035
Country
Ukraine
City
Kyiv
ZIP/Postal Code
01021
Country
Ukraine
City
Lugansk
ZIP/Postal Code
91017
Country
Ukraine
City
Lviv
ZIP/Postal Code
81130
Country
Ukraine
City
Makeevka
ZIP/Postal Code
86106
Country
Ukraine
City
Odessa
ZIP/Postal Code
65006
Country
Ukraine
City
Poltava
ZIP/Postal Code
314039
Country
Ukraine
City
Rivne
ZIP/Postal Code
33028
Country
Ukraine
City
Simferopol
ZIP/Postal Code
95006
Country
Ukraine
City
Ternopil
ZIP/Postal Code
46006
Country
Ukraine
City
Uzhhorod
ZIP/Postal Code
88011
Country
Ukraine
City
Zaporizhzhia
ZIP/Postal Code
69063
Country
Ukraine
12. IPD Sharing Statement
Learn more about this trial
Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa
We'll reach out to this number within 24 hrs