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

Condition(s) targeted: Contraception

Intervention: YAZ (SH T00186 DF) (Drug); YAZ extended (SH T 04210 A) (Drug); YAZ extended (SH T 04210 A) (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.

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

Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Number of days with bleeding/spotting

Number of unintended pregnancies (Pearl Index, life table analysis)

Secondary outcome: Parameters of safety and tolerability

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.

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Healthy women who desire contraception

Exclusion Criteria:

- Contraindication against use of hormonal contraceptives

Quebec G1S 2L6, Canada

Karlsruhe, Baden-Württemberg / 275 76199, Germany

Ettlingen, Baden-Württemberg / 275 76275, Germany

Nürnberg, Bayern / 280 90491, Germany

Krumbach, Bayern / 280 86381, Germany

Ansbach, Bayern / 280 91522, Germany

Berlin, Berlin / 285 13187, Germany

Berlin, Berlin / 285 10115, Germany

Berlin, Berlin / 285 10247, Germany

Berlin, Berlin / 285 12435, Germany

Groningen, GZ 9713, Netherlands

Hamburg, Hamburg / 287 21073, Germany

Dietzenbach, Hessen / 307 63128, Germany

Frankfurt, Hessen / 307 65929, Germany

Frankfurt, Hessen / 307 60439, Germany

Frankfurt, Hessen / 307 60322, Germany

Frankfurt, Hessen / 307 65936, Germany

Mühlheim, Hessen / 307 63165, Germany

Osnabrück, Niedersachsen 49074, Germany

Bovenden, Niedersachsen / 290 37120, Germany

Hannover, Niedersachsen / 291 30459, Germany

Ste-Foy, Quebec GIV 4X7, Canada

Shawinigan, Quebec G9N 2H6, Canada

Montreal, Quebec H1T 1P6, Canada

Drummondville, Quebec J2B 1H8, Canada

Pointe-Claire, Quebec H9R 4S3, Canada

Wurzen, Sachsen / 313 04808, Germany

Magdeburg, Sachsen-Anhalt / 311 39112, Germany

Magdeburg, Sachsen-Anhalt / 311 39104, Germany

Bernburg, Sachsen-Anhalt / 311 06406, Germany

Jessen, Sachsen-Anhalt / 311 06917, Germany

Magdeburg, Sachsen-Anhalt / 311 39130, Germany

Gera, Thüringen / 310 07545, Germany

Jena, Thüringen / 310 07747, Germany

Kahla, Thüringen / 310 07768, Germany

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Starting date: December 2005
Ending date: November 2008
Last updated: April 25, 2008