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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00280657
First Posted: January 23, 2006
Last Update Posted: December 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • ISGA [ Time Frame: 6 months ]
  • Parameters of safety and tolerability [ Time Frame: 6 months ]

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patients with mild to moderate facial papulopustular acne

Exclusion Criteria:

  • Contraindication against use of hormonal contraceptives
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280657


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00280657     History of Changes
Other Study ID Numbers: 91299
307760
First Submitted: January 20, 2006
First Posted: January 23, 2006
Last Update Posted: December 18, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Acne papulopustulosa

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs