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ContraceptionPhase 3NCT07536763

Arterial Vascular Effects of Estetrol-drospirenone Combined Oral Contraceptive Pill

A Phase 3 study testing Estetrol-drospirenone and Ethinylestradiol-levonorgestrel in people with Contraception, run by Dr. Hang Wun Raymond Li.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
Estetrol-drospirenone and Ethinylestradiol-levonorgestrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
No sites listed yet
Study dates
Jul 2026to Jun 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged between 18 and 49 years inclusive
  • Considering to use the COC pill for contraception or treatment of menstrual disorders

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Raymond HW Li, MD, FRCOG contact

+852 22554517

raymondli@hku.hk

Jennifer KY Ko, MBBS, FRCOG contact

+852 22554517

jenko@hku.hk

About this study

Official title: Effect of Estetrol-drospirenone Combined Oral Contraceptive Pill on Arterial Vascular Risks

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:

Read more

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
Read the 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.

Conditions
Contraception
Being tested
Estetrol-drospirenone, Ethinylestradiol-levonorgestrel
Keywords
Estetrol-drospirenone, Ethinylestradiol-levonorgestrel, Combined oral contraceptives, Arterial risks, Metabolic risks

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Estetrol-drospirenoneDrug

    Also called Alyssa

    Estetrol 15mg + drospirenone 3mg

  • Ethinylestradiol-levonorgestrelDrug

    Also called Microgynon

    Ethinylestradiol 30mcg + levonorgestrel 150mcg

Study groups in NCT07536763
Study groupRoleWhat they receive
E4-drospirenoneExperimentalEstetrol-drospirenone
Receives: Drug: Estetrol-drospirenone
EE-levonorgestrelActive comparatorEthinylestradiol-levonorgestrel
Receives: Drug: Ethinylestradiol-levonorgestrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Flow-mediated dilatation (FMD)

    Flow-mediated dilatation of the brachial artery

    Measured: 0, 6 and 12 months

Secondary outcomes (11)

  1. Pulse wave velocity (PWV)

    Pulse wave velocity (carotid-femoral and brachial-ankle)

    Measured: 0, 6 and 12 months

  2. Body mass index

    Body mass index

    Measured: 0, 6 and 12 months

  3. Waist-hip ratio

    Waist-hip ratio

    Measured: 0, 6 and 12 months

  4. Blood pressure

    Blood pressure (systolic and diastolic)

    Measured: 0, 6 and 12 months

  5. Sex hormone-binding globulin

    Serum sex hormone-binding globulin level

    Measured: 0, 6 and 12 months

  6. High sensitivity C-reactive protein

    Serum high sensitivity C-reactive protein level

    Measured: 0, 6 and 12 months

  7. Fasting glucose

    Fasting plasma glucose

    Measured: 0, 6 and 12 months

  8. 2-hour glucose

    Plasma glucose at 2 hours after 75g oral glucose tolerance test

    Measured: 0, 6 and 12 months

  9. Haemoglobin A1c

    Haemoglobin A1c

    Measured: 0, 6 and 12 months

  10. Fasting insulin

    Serum fasting insulin level

    Measured: 0, 6 and 12 months

  11. Lipid profile

    Lipid profile (low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides)

    Measured: 0, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionJun 2029 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07536763
Sponsor's protocol ID
UW 26-044
Status last verified
Apr 2026
First submitted
12 Apr 2026
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD may be shared upon negotiation with reasonable justifications after publication of the results.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Estetrol-drospirenone and Ethinylestradiol-levonorgestrel in people with Contraception, run by Dr. Hang Wun Raymond Li.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Raymond HW Li, MD, FRCOG (+852 22554517, raymondli@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Flow-mediated dilatation (FMD) (time frame: 0, 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07536763.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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