Arterial Vascular Effects of Estetrol-drospirenone Combined Oral Contraceptive Pill
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
Timeline
- Start
- 2026-07
- Primary completion
- 2029-06
- Completion
- 2029-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ESTETROL ANHYDROUS | Other / unclassified | 15 mg | Oral |
| Comparator | Levonorgestrel | Small molecule | 150 ug | Oral |
| Subject | drospirenone | Unknown | 3 mg | Oral |
| Comparator | ethinyl estradiol | Small molecule | 30 ug | Oral |
Indications
No indication recorded.