Trial Profile

A Randomized, Double-blind, Double-dummy, 2-parallel Arms Clinical Trial to Assess the Pharmacodynamic Effect on Plasma Folate and Red Blood Cell Folate and to Compare the Profile of Circulating Folate Metabolites During 24 Weeks of Treatment With an Oral Contraceptive Containing Ethinylestradiol, Drospirenone and L-5-methyltetrahydrofolate (SH T04532A and SH T04532C) or Yasmin (SH T04532D and SH T04532PC) Co-administered With Folic Acid (SH K04532B) Followed by 20 Weeks of Open-label Treatment With Yasmin Only (Folate Elimination Phase) in Women Seeking Contraception.

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 08 Nov 2021

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At a glance

Drugs Drospirenone/ethinylestradiol (Primary) ; Ethinylestradiol/drospirenone/levomefolic acid (Primary) ; Folic acid
Indications Pregnancy
Focus Pharmacodynamics; Pharmacokinetics
Sponsors Bayer

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