Arterial Vascular Effects of Estetrol-drospirenone Combined Oral Contraceptive Pill
ClinicalTrials.gov Studies
Summary
The NIH registered a Phase 3 clinical trial (NCT07536763) comparing estetrol-drospirenone combined oral contraceptive pills against ethinylestradiol-levonorgestrel pills. The trial will evaluate effects on arterial vascular function including flow-mediated dilatation and pulse wave velocity, blood pressure, inflammatory markers, and metabolic indices over 12 months. Participants are randomized to receive either treatment with clinic visits at baseline, 6 months, and 12 months.
What changed
The NIH registered a new Phase 3 clinical trial on ClinicalTrials.gov under identifier NCT07536763. The trial investigates whether estetrol-drospirenone combined oral contraceptive pills have smaller effects on arterial vascular function compared to ethinylestradiol-levonorgestrel pills, measuring flow-mediated dilatation, pulse wave velocity, blood pressure, inflammatory markers, and metabolic indices.
Pharmaceutical companies, clinical investigators, and healthcare providers involved in contraceptive drug development or prescribing should note this comparative safety study. The trial's focus on vascular and metabolic effects addresses regulatory interest in characterizing cardiovascular safety profiles of newer versus established oral contraceptive formulations. No compliance obligations arise from this registry entry.
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Arterial Vascular Effects of Estetrol-drospirenone Combined Oral Contraceptive Pill
Phase 3 NCT07536763 Kind: PHASE3 Apr 17, 2026
Abstract
The goals of this clinical trial are to investigate the effect of the estetrol (E4)-drospirenone combined oral contraceptive (COC) pill on flow-mediated dilatation (FMD) of the brachial artery and pulse wave velocity (PWV), in comparison to the ethinylestradiol (EE)-levonorgestrel COC pill, and to compare their respective effects on blood pressure, chronic inflammatory markers, as well as glycaemic and lipid indices.
The main questions it aims to answer are:
Does E4-drospirenone COC have significantly smaller effects then EE-levonorgestrel COC on FMD, PWV, blood pressure, chronic inflammatory markers, as well as glycemic and lipid indices.
Researchers will compare E4-drospirenone to EE-levonorgestrel to see if the former has lower arterial vascular and metabolic risks.
Participants will:
- be randomised to take E4-drospirenone or EE-levonorgestrel COC pill according to product insert;
- visit the clinic at baseline and 6 and 12 months post-recruitment for checkups and tests
Conditions: Contraception
Interventions: Estetrol-drospirenone, Ethinylestradiol-levonorgestrel
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