The Influence of Plan B® on Cardiovascular Health.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorMcMaster University
About this trial
The goal of this double-blind randomized controlled trial is to learn about the impacts of a single dose of Plan B® on the cardiovascular system in young, health, premenopausal females. The main questions it aims to answer are:
1. What is the short-term affect of Plan B® affect on the venous system? 2. What is the short-term affect of Plan B® affect on the health of arteries?
Researchers will compare a single dose of Plan B® (1.5 mg of levonorgestrel) to a placebo to see if Plan B® has unique effects on the cardiovascular system.
Participants will:
1. Undergo baseline measurements of venous thrombosis markers, blood pressure, and measures of arterial function using ultrasound. 2. Be randomized to either take a Plan B® or placebo pill 3. Repeat baseline measurements of venous thrombosis markers, blood pressure, and measures of arterial function using ultrasound each hour, for 6-hours, and then 24- and 48- hours after taking the Plan B® or placebo pill.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provide written informed consent.
Pre-menopausal female.
18 - 35 years of age.
Naturally cycling (i.e., not using any form of hormonal contraception for ≥ 3 months).
Disqualifiers
Known hypersensitivity to the active substance levonorgestrel or to any ingredient in this formulation (i.e., levonorgestrel colloidal silicon dioxide, potato starch, magnesium stearate, talc, cornstarch, lactose monohydrate, or any ingredient/excipient in the placebo capsule.
Known or suspected pregnancy.
At risk of the development of unwanted pregnancy within the past 72 hours.
Known, suspected, or history of cardiovascular, metabolic, or musculoskeletal disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Plan B (Levonorgestrel)
Drug1 x dose of 1.5 mg levonorgestrel tablet over encapsulated to mimic placebo.
Placebo (gelatin capsule)
Other interventionGelatin capsule over encapsulated to mimic Plan B
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Plan B®Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
D-Dimer
Measured in ug/L FEU from platelet poor plasma using the HemosIL® D-Dimer HS 500 assay, a latex immunoturbidimetric assay (LIA) on the ACL TOP analyzer.
Time frame
Baseline, 1-hour, 2-hours, 3-hours, 4-hours, 5-hours, 6-hours, 24-hours and 48-hours post-ingestion of Plan B/placebo2
Prothrombin fragment 1+2
Measured in pg/mL from platelet-poor plasma using an enzyme-linked immunosorbent assay (ELISA).
Time frame
Baseline, 1-hour, 2-hours, 6-hours, 24-hours, and 48-hours post-ingestion of Plan B/placebo.3
Thrombin antithrombin
Measured in pg/mL from platelet-poor plasma using an enzyme-linked immunosorbent assay (ELISA).
Time frame
Baseline, 1-hour, 2-hours, 6-hours, 24-hours, and 48-hours post-ingestion of Plan B/placebo.4
P-Selectin
Measured in pg/mL from platelet-poor plasma using an enzyme-linked immunosorbent assay (ELISA).
Time frame
Baseline, 1-hour, 2-hours, 6-hours, 24-hours, and 48-hours post-ingestion of Plan B/placebo.Secondary outcomes
1
Brachial artery flow-mediated dilation
Measured as the percent change in brachial artery diameter from baseline to peak dilation following reactive hyperemia (%FMD).
Time frame
Baseline, 1-hour, 2-hours, 3-hours, 4-hours, 5-hours, 6-hours, 24-hours and 48-hours post-ingestion of Plan B/placebo2
Levonorgestrel
Measured in pg/mL from serum using an enzyme-linked immunosorbent assay (ELISA).
Time frame
1-hour, 2-hours, 3-hours, 4-hours, 5-hours, 6-hours, 24-hours and 48-hours post-ingestion of Plan B/placebo3
Systolic blood pressure
Measured in millimeters of mercury (mmHg)
Time frame
Baseline, 1-hour, 2-hours, 3-hours, 4-hours, 5-hours, 6-hours, 24-hours and 48-hours post-ingestion of Plan B/placebo4
Diastolic blood pressure
Measured in millimeters of mercury (mmHg)
Time frame
Baseline, 1-hour, 2-hours, 3-hours, 4-hours, 5-hours, 6-hours, 24-hours and 48-hours post-ingestion of Plan B/placeboSponsors and contacts
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Source ClinicalTrials.gov