Health TrialsbyHealthPanel

Arterial Vascular Effects of Estetrol-drospirenone Combined Oral Contraceptive Pill

ConditionContraception
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorDr. Hang Wun Raymond Li

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged between 18 and 49 years inclusive

Considering to use the COC pill for contraception or treatment of menstrual disorders

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Estetrol-drospirenone

    Drug

    Estetrol 15mg + drospirenone 3mg

  • Ethinylestradiol-levonorgestrel

    Drug

    Ethinylestradiol 30mcg + levonorgestrel 150mcg

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: E4-drospirenoneExperimental treatment 1 intervention
Group B: EE-levonorgestrelActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Flow-mediated dilatation (FMD)

Flow-mediated dilatation of the brachial artery

Time frame
0, 6 and 12 months

Secondary outcomes

1

Pulse wave velocity (PWV)

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

Time frame
0, 6 and 12 months
2

Body mass index

Body mass index

Time frame
0, 6 and 12 months
3

Waist-hip ratio

Waist-hip ratio

Time frame
0, 6 and 12 months
4

Blood pressure

Blood pressure (systolic and diastolic)

Time frame
0, 6 and 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Hang Wun Raymond Li

Lead sponsor

The University of Hong Kong

Sponsor institution

The Family Planning Association of Hong Kong

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: