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Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles - Article


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Contraception

Condom; Condoms




Clinical Trial: Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles

This study is not yet open for patient recruitment.
Verified by Schering AG, Germany December 2005

Sponsored by: Schering AG, Germany
Information provided by: Schering AG, Germany
ClinicalTrials.gov Identifier: NCT00266032

Purpose

The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.
Condition Intervention Phase
Contraception
 Drug: SH T 00186 D
Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Multicenter, Open, Randomized, Parallel-Group Comparison to Assess the Safety and Efficacy of the Oral Contraceptive SH T 00186 D in Extended Cycles Vs. a Standard Regimen in Healthy Female Volunteers for Up to Two Years

Further study details as provided by Schering AG, Germany:
Primary Outcomes: Number of days with bleeding/spotting
Secondary Outcomes: Parameters of safety and tolerability; Number of unintended pregnancies

Study start: December 2005

Eligibility

Ages Eligible for Study:  18 Years   -   35 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Healthy women who desire contraception

Exclusion Criteria:

  • Contraindication against use of hormonal contraceptives

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00266032

Schering AG, Germany, Medical affairs      Europe: +49 30 46811800 
Schering AG Germany, Medical affairs      Canada: +1 8665969652 

Canada, Quebec
      Ste Foy,  Quebec,  G1V 4P9,  Canada

      Shawinigan,  Quebec,  G9N 2H6,  Canada

      Québec,  Quebec,  G1S 2L6,  Canada

      Montreal,  Quebec,  H1T 1P6,  Canada

      Drummondville,  Quebec,  J2B 1H8,  Canada

      Pointe-Claire,  Quebec,  H9R 4S3,  Canada

Germany
      Berlin,  13187,  Germany

      Berlin,  10115,  Germany

      Berlin,  10247,  Germany

      Berlin,  12435,  Germany

      Hamburg,  Pract: 21073 / Mail: 21149,  Germany

Germany, Baden-Württemberg
      Karlsruhe,  Baden-Württemberg,  76199,  Germany

      Ettlingen,  Baden-Württemberg,  76275,  Germany

Germany, Bayern
      Nürnberg,  Bayern,  90461,  Germany

      Krumbach,  Bayern,  86381,  Germany

      Ansbach,  Bayern,  91522,  Germany

Germany, Hessen
      Dietzenbach,  Hessen,  63128,  Germany

      Frankfurt/Main,  Hessen,  65929,  Germany

      Frankfurt/Main,  Hessen,  60439,  Germany

      Frankfurt/Main,  Hessen,  60322,  Germany

      Frankfurt/Main,  Hessen,  65936,  Germany

      Mühlheim,  Hessen,  63165,  Germany

Germany, Niedersachsen
      Osnabrück,  Niedersachsen,  49074,  Germany

      Hannover,  Niedersachsen,  30459,  Germany

      Bovenden,  Niedersachsen,  37120,  Germany

Germany, Saarland
      HOMBURG / SAAR,  Saarland,  66421,  Germany

Germany, Sachsen
      Wurzen,  Sachsen,  04808,  Germany

Germany, Sachsen-Anhalt
      Magdeburg,  Sachsen-Anhalt,  39112,  Germany

      Magdeburg,  Sachsen-Anhalt,  39104,  Germany

      Bernburg,  Sachsen-Anhalt,  06406,  Germany

      Jessen,  Sachsen-Anhalt,  06917,  Germany

      Magdeburg,  Sachsen-Anhalt,  39130,  Germany

Germany, Thüringen
      Gera,  Thüringen,  07545,  Germany

      Jena,  Thüringen,  07747,  Germany

      Kahla,  Thüringen,  07768,  Germany

      Gera,  Thüringen,  07545,  Germany

Netherlands
      Groningen,  9713 GZ,  Netherlands

Study chairs or principal investigators

Schering AG, Germany Medical Affairs,  Study Director,  Phone Europe: +49 30 46811800, Phone Canada: +1 8665969652   

More Information

Study ID Numbers:  308683
Last Updated:  December 14, 2005
Record first received:  December 14, 2005
ClinicalTrials.gov Identifier:  NCT00266032
Health Authority: Canada: Health Canada; Germany: Federal Institute for Drugs and Medicinal Devices; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2006-01-10

Resources



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December 4, 2008



Page Updated: October 3, 2005
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