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A Multi-center, Double-blind, Double-dummy, Controlled, Randomized Study to Evaluate Cycle Control and Safety of a Four Phasic Oral Contraceptive (SH T00658ID) in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D 593 B) in Healthy Female Volunteers Aged Between 18 and 50 Years.

Trial Profile

A Multi-center, Double-blind, Double-dummy, Controlled, Randomized Study to Evaluate Cycle Control and Safety of a Four Phasic Oral Contraceptive (SH T00658ID) in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D 593 B) in Healthy Female Volunteers Aged Between 18 and 50 Years.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Dec 2020

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At a glance

  • Drugs Estradiol valerate/dienogest (Primary) ; Ethinylestradiol/levonorgestrel
  • Indications Pregnancy
  • Focus Registrational; Therapeutic Use
  • Sponsors Bayer HealthCare Pharmaceuticals

Most Recent Events

  • 01 Dec 2009 Results published in Contraception.
  • 12 May 2009 Actual patient number (798) added as reported by ClinicalTrials.gov.
  • 22 Sep 2006 Status change

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