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
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
Treatments tested in this trial
- Estetrol-drospirenone
- Ethinylestradiol-levonorgestrel
Treatment groups
98 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
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