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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: January 20, 2006
Last updated: December 17, 2014
Last verified: December 2014
The purpose of the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa.

Condition Intervention Phase
Acne Vulgaris
Drug: Valette
Drug: Diane
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change in lesions [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ISGA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Parameters of safety and tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 1326
Study Start Date: March 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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

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.

Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with mild to moderate facial papulopustular acne

Exclusion Criteria:

  • Contraindication against use of hormonal contraceptives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00280657

  Show 62 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00280657     History of Changes
Other Study ID Numbers: 91299  307760 
Study First Received: January 20, 2006
Last Updated: December 17, 2014
Health Authority: Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Bayer:
Acne papulopustulosa

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Ethinyl Estradiol
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on January 18, 2017