Trial Profile

Open-label, Randomized, Fixed Sequence Cross-over Study With Five Parallel Treatment Arms and Three Treatment Periods to Quantify the Drug-drug Interactions of Two Rifampicin Dose Strengths on Four Progestins and a Fixed Progestin-ethinylestradiol Combination Compared With Midazolam in Healthy Post-menopausal Women

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 16 Apr 2020

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At a glance

Drugs Desogestrel (Primary) ; Dienogest (Primary) ; Drospirenone/ethinylestradiol (Primary) ; Drospirenone/ethinylestradiol (Primary) ; Levonorgestrel (Primary) ; Midazolam (Primary) ; Norethisterone (Primary) ; Rifampicin (Primary) ; Rifampicin (Primary)
Indications Acne; Adenomyosis; Endometriosis; Menopausal syndrome
Focus Pharmacokinetics
Sponsors Bayer

15 Apr 2020 New trial record
10 Apr 2020 Results evaluating effects of weak and strong CYP3A induction by rifampicin on the pharmacokinetics of five progestins and ethinylestradiol compared to midazolam, published in the Clinical Pharmacology and Therapeutics

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