NCT07536763

Brief 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P25-P50 for phase_3

Timeline
36mo left

Started Jul 2026

Typical duration for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

April 12, 2026

Last Update Submit

April 24, 2026

Conditions

Contraception

Keywords

Estetrol-drospirenoneEthinylestradiol-levonorgestrelCombined oral contraceptivesArterial risksMetabolic risks

Outcome Measures

Primary Outcomes (1)

  • Flow-mediated dilatation (FMD)

    Flow-mediated dilatation of the brachial artery

    0, 6 and 12 months

Secondary Outcomes (11)

  • Pulse wave velocity (PWV)

    0, 6 and 12 months

  • Body mass index

    0, 6 and 12 months

  • Waist-hip ratio

    0, 6 and 12 months

  • Blood pressure

    0, 6 and 12 months

  • Sex hormone-binding globulin

    0, 6 and 12 months

  • +6 more secondary outcomes

Study Arms (2)

E4-drospirenone

EXPERIMENTAL

Estetrol-drospirenone

Drug: Estetrol-drospirenone

EE-levonorgestrel

ACTIVE COMPARATOR

Ethinylestradiol-levonorgestrel

Drug: Ethinylestradiol-levonorgestrel

Interventions

Ethinylestradiol-levonorgestrelDRUG

Ethinylestradiol 30mcg + levonorgestrel 150mcg

Also known as: Microgynon
EE-levonorgestrel
Estetrol-drospirenoneDRUG

Estetrol 15mg + drospirenone 3mg

Also known as: Alyssa
E4-drospirenone

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCisgender female only
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

drospirenone and estetrolethinyl estradiol, levonorgestrel drug combination

Study Officials

  • Raymond HW Li, MD, FRCOG

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond HW Li, MD, FRCOG

CONTACT

+852 22554517raymondli@hku.hk

Jennifer KY Ko, MBBS, FRCOG

CONTACT

+852 22554517jenko@hku.hk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

April 12, 2026

First Posted

April 17, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

IPD may be shared upon negotiation with reasonable justifications after publication of the results.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
After publication of the results.
Access Criteria
IPD may be shared upon negotiation with reasonable justifications after publication of the results.