Arterial Vascular Effects of Estetrol-drospirenone Combined Oral Contraceptive Pill

Sponsor
Dr. Hang Wun Raymond Li
Study ID
NCT07536763
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Contraception

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • Estetrol-drospirenone — DRUG
    Estetrol 15mg + drospirenone 3mg
  • Ethinylestradiol-levonorgestrel — DRUG
    Ethinylestradiol 30mcg + levonorgestrel 150mcg

Study Details

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 Dates

First listed
Apr 17, 2026
Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: E4-drospirenone
    Estetrol-drospirenone
  • Active Comparator: EE-levonorgestrel
    Ethinylestradiol-levonorgestrel

Primary Outcome Measure

Flow-mediated dilatation (FMD) [ Time Frame: 0, 6 and 12 months ]

Central Contacts

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