Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa

June 5, 2023 updated by: Bayer

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1326

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with mild to moderate facial papulopustular acne

Exclusion Criteria:

  • Contraindication against use of hormonal contraceptives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: 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
Experimental: Arm 1
Drug: 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
Placebo Comparator: Arm 3
Drug: Placebo
2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in lesions
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
ISGA
Time Frame: 6 months
6 months
Parameters of safety and tolerability
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2004

Primary Completion (Actual)

May 21, 2005

Study Completion (Actual)

May 21, 2005

Study Registration Dates

First Submitted

January 20, 2006

First Submitted That Met QC Criteria

January 20, 2006

First Posted (Estimated)

January 23, 2006

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91299
  • 307760

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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