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A Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparative Study to Investigate the Optimal Dose of Drospirenone for Dysmenorrhea With SH T04740A [Drospirenone 1 mg/Ethinylestradiol 20 microg (as beta-Cyclodextrin Clathrate)], SH T 04740E [Drospirenone 2 mg/Ethinylestradiol 20 μg (as beta-Cyclodextrin Clathrate)] and SH T00186D [Drospirenone 3 mg/ Ethinylestradiol 20 microg (as beta-Cyclodextrin Clathrate)] Administered Orally for 16 Weeks (4 Cycles), and to Confirm the Efficacy of SH T00186D for Dysmenorrhea.

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Trial Profile

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparative Study to Investigate the Optimal Dose of Drospirenone for Dysmenorrhea With SH T04740A [Drospirenone 1 mg/Ethinylestradiol 20 microg (as beta-Cyclodextrin Clathrate)], SH T 04740E [Drospirenone 2 mg/Ethinylestradiol 20 μg (as beta-Cyclodextrin Clathrate)] and SH T00186D [Drospirenone 3 mg/ Ethinylestradiol 20 microg (as beta-Cyclodextrin Clathrate)] Administered Orally for 16 Weeks (4 Cycles), and to Confirm the Efficacy of SH T00186D for Dysmenorrhea.

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 18 Sep 2021

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At a glance

  • Drugs Drospirenone/ethinylestradiol (Primary)
  • Indications Dysmenorrhoea
  • Focus Therapeutic Use
  • Most Recent Events

    • 26 Jan 2017 Biomarkers information updated
    • 18 Mar 2009 Actual patient number (243) added as reported by ClinicalTrials.gov.
    • 18 Mar 2009 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.

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