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A Pivotal, Multicentre, Double-Blind, Double-Dummy, Randomised Trial on the Contraceptive Efficacy, Tolerability and Safety of LF111 (Drospirenone) Over 9 Cycles in Comparison With Desogestrel 0.075 mg

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Trial Profile

A Pivotal, Multicentre, Double-Blind, Double-Dummy, Randomised Trial on the Contraceptive Efficacy, Tolerability and Safety of LF111 (Drospirenone) Over 9 Cycles in Comparison With Desogestrel 0.075 mg

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Dec 2022

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At a glance

  • Drugs Desogestrel (Primary) ; Drospirenone (Primary)
  • Indications Pregnancy
  • Focus Registrational; Therapeutic Use
  • Sponsors Leon Farma
  • Most Recent Events

    • 26 Oct 2022 Results of a post-hoc cluster analysis from two phase III studies assessing efficacy, safety and tolerability of drospirenone 4mg presented at the 78th Scientific Congress of the American Society for Reproductive Medicine
    • 28 May 2022 Results of an analysis assessed the metabolic effects of the 4 mg drospirenone-only pill compared to 75 µg desogestrel presented at the 16th Congress of the European Society of Contraception and Reproductive Health
    • 28 May 2022 Results evaluating acceptability of the bleeding pattern comparing to a traditional desogestrel 0.075 mg (DSG)-POP, presented at the 16th Congress of the European Society of Contraception and Reproductive Health

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