Not Yet RecruitingPhase 3

Arterial Vascular Effects of Estetrol-drospirenone Combined Oral Contraceptive Pill

98 participantsStarted 2026-07

Plain-language summary

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

Who can participate

Age range18 Years – 49 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged between 18 and 49 years inclusive * Considering to use the COC pill for contraception or treatment of menstrual disorders Exclusion Criteria: * 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

What they're measuring

Flow-mediated dilatation (FMD)

Timeframe: 0, 6 and 12 months

Trial details

NCT IDNCT07536763

SponsorDr. Hang Wun Raymond Li

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-06

Contact for this trial

Raymond HW Li, MD, FRCOG

+852 22554517 raymondli@hku.hk