Arterial Vascular Effects of Estetrol-drospirenone Combined Oral Contraceptive Pill
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Estetrol-drospirenone, Ethinylestradiol-levonorgestrel.
- Who it may be relevant to
- Registry conditions: Contraception. Basic parameters: 18 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Estetrol-drospirenone Combined Oral Contraceptive Pill on Arterial Vascular Risks
Overview
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
Detailed description
Objectives: (1) 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 ethinyl-estradiol (EE)- levonorgestrel COC pill. (2) To investigate the effect of the E4-drospirenone COC pill on blood pressure, chronic inflammatory markers, as well as glycaemic /lipid indices.
Hypothesis to be tested: E4-drospirenone has non-significant effect on FMD and PWV, as well as on blood pressure, chronic inflammatory markers, glycaemic and lipid profile compared to EE-levonorgestrel.
Design and subjects: Open-label randomised controlled trial. Women (n=98) who are commencing COC pills for contraception or treatment of gynaecological conditions will be recruited.
Study instruments: FMD, carotid-femoral and brachial-ankle PWV, blood pressure, serum high-sensitivity C-reactive protein and interleukin-6 measurements, glycaemic and lipid profile
Interventions: (1) E4 15mg + drospirenone 3mg versus (2) EE 30mcg + levonorgestrel 150mcg
Main outcome measures: FMD, carotid-femoral and brachial-ankle PWV
Data analysis: Data will be analysed with both intention to treat and per protocol approaches. The primary and secondary outcome measures (continuous variables) at baseline and at 6 and 12 months after treatment will be compared by paired t-test (with logarithmic transformation of significantly skewed data). Changes in these parameters will be compared between the two study groups by linear mixed models. P values of \<0.05 will be considered statistically significant.
Expected results: E4-drospirenone induces insignificant changes in FMD, PWV as well as blood pressure, chronic inflammatory markers, and glycaemic and lipid profile.
Interventions
- Drug Estetrol-drospirenone
Estetrol 15mg + drospirenone 3mg - Drug Ethinylestradiol-levonorgestrel
Ethinylestradiol 30mcg + levonorgestrel 150mcg
Primary outcome measures
- Flow-mediated dilatation (FMD) [Time frame: 0, 6 and 12 months]
Secondary outcome measures (11)
- Pulse wave velocity (PWV) [Time frame: 0, 6 and 12 months]
- Body mass index [Time frame: 0, 6 and 12 months]
- Waist-hip ratio [Time frame: 0, 6 and 12 months]
- Blood pressure [Time frame: 0, 6 and 12 months]
- Sex hormone-binding globulin [Time frame: 0, 6 and 12 months]
- High sensitivity C-reactive protein [Time frame: 0, 6 and 12 months]
- Fasting glucose [Time frame: 0, 6 and 12 months]
- 2-hour glucose [Time frame: 0, 6 and 12 months]
- Haemoglobin A1c [Time frame: 0, 6 and 12 months]
- Fasting insulin [Time frame: 0, 6 and 12 months]
- Lipid profile [Time frame: 0, 6 and 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07536763 · UW 26-044