A Single-center, Open-label, Fixed-sequence Trial to Investigate the Effect of Multiple-dose Aprocitentan on the Single-dose Pharmacokinetics of Combined Oral Contraceptives in Healthy Female Participants

The goal of this clinical trial is to learn if drug aprocitentan has an effect on hormonal contraceptives in healthy female volunteers. The main question it aims to answer is:
Does aprocitentan modify the fate of hormonal contraceptives in the body?
Trial participants will:
* Take a single dose of hormonal contraceptives (fixed combination) alone
* Take aprocitentan every day for 2 weeks
* Take a single dose of the same hormonal contraceptives at the same time as the 10th administration of aprocitentan.

Start Date18 Jan 2025

Sponsor / Collaborator

Idorsia Pharmaceuticals Ltd.

NCT04142762

/ CompletedPhase 1

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate CYP3A4-Mediated, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adult Subjects

This study is designed to assess 1) the effect of multiple doses of itraconazole (CYP3A4 inhibitor), rifampin (CYP3A4 inducer), and esomeprazole (pH modifier) on the pharmacokinetics of a single oral dose of ABI-H2158, and 2) the effect of steady-state oral ABI-H2158 on the pharmacokinetics of midazolam (sedative) and levonorgestrel/ethinyl estradiol (active oral contraceptive) in healthy adult participants.

Start Date18 Oct 2019

Sponsor / Collaborator

Assembly Biosciences, Inc.

NCT03359057

/ CompletedPhase 3IIT

Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel (Ethinyl Estradiol + Levonorgestrel + Folic Acid - Coated Tablet - 0.02 mg + 0.10 mg + 0.4 mg; Biolab Sanus Farmaceutica Ltda) in Female Volunteers.

This trial evaluated folic acid supplementation after oral administration of the ethinyl estradiol + levonorgestrel + folic acid (0.02 mg + 0.10 mg + 0.4 mg) coated tablet (Level-Fol® Biolab Sanus Farmacêutica, São Paulo, Brazil) in healthy female volunteers, based on statistical comparisons of folate levels in erythrocytes. Its safety and tolerability was also evaluated.

Start Date26 Feb 2013

Sponsor / Collaborator

BIOLAB SANUS Farmacêutica Ltda.

100 Clinical Results associated with Ethinyl estradiol/levonorgestrel/ferrous fumarate

100 Translational Medicine associated with Ethinyl estradiol/levonorgestrel/ferrous fumarate

100 Patents (Medical) associated with Ethinyl estradiol/levonorgestrel/ferrous fumarate

100 Deals associated with Ethinyl estradiol/levonorgestrel/ferrous fumarate

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Contraception	United States	Cadence Health, Inc.Startup	26 Jul 1979

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