Arterial Vascular Effects of Estetrol-drospirenone Combined Oral Contraceptive Pill
Starting soon · Phase 3
Conditions studied: Contraception
In brief
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
Key facts
- Study ID
- NCT07536763
- Run by
- Dr. Hang Wun Raymond Li
- People needed
- 98
- Starts
- 2026-07-01
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2026-04-27
Who can join
Age: 18 and older, up to 49. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Aged between 18 and 49 years inclusive
- Considering to use the COC pill for contraception or treatment of menstrual disorders
You may not qualify if…
- Being diagnosed with menopause
- Having contraindications to COC, including (but not confined to) hypertension, diabetes mellitus with complications, history of ischaemic heart disease, thromboembolism, stroke, severe liver disease, oestrogen-sensitive cancers, undiagnosed abnormal uterine bleeding, smokers aged 35 years or above, or having body mass index >=35 kg/m2
- Planning to get pregnant in the coming 1 year
- Having been pregnant in the past 3 months
- Having been on COC or hormone replacement therapy in the past 3 months (those who had been on these agents can stop these for 3 months as wash-out period before being recruited; this concurs with other similar studies in the literature)
- Having been on anti-hypertensive, anti-diabetic or lipid-lowering agents in the past 3 months
- Refusal to randomization
Full record on ClinicalTrials.gov
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