The Influence of a Single Dose of Emergency Contraception on Markers of Venous Thrombosis and Vascular Function in Young, Healthy Females.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- McMaster University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- D-Dimer
Study Overview
Brief Summary
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:
- What is the short-term affect of Plan B® affect on the venous system?
- 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:
- Undergo baseline measurements of venous thrombosis markers, blood pressure, and measures of arterial function using ultrasound.
- Be randomized to either take a Plan B® or placebo pill
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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).
- •Eumenorrheic (i.e., experiencing a predictable menstrual cycle lasting 21-45 days).
- •In the surrounding Hamilton area, or able to visit McMaster for study visits.
- •Not pregnant.
Exclusion Criteria
- •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.
- •Undiagnosed abnormal vaginal bleeding.
- •Use of anti-HIV drugs, anticonvulsant drugs, antibiotics, rifampicin/rifabutin, ulipristal acetate, Griseofulvin, Hypericum perforatum (St John's wort) or any other drug that may interfere with the normal pharmacokinetic or pharmacodynamic characteristics of the study intervention.
- •Active or history of migraine.
- •A condition or factor that would prevent the use of Plan B®.
Arms & Interventions
Plan B®
1.5 mg Levonorgestrel
Intervention: Plan B (Levonorgestrel) (Drug)
Placebo
Gelatin capsule
Intervention: Placebo (gelatin capsule) (Other)
Outcomes
Primary Outcomes
D-Dimer
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/placebo
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.
Prothrombin fragment 1+2
Time Frame: Baseline, 1-hour, 2-hours, 6-hours, 24-hours, and 48-hours post-ingestion of Plan B/placebo.
Measured in pg/mL from platelet-poor plasma using an enzyme-linked immunosorbent assay (ELISA).
Thrombin antithrombin
Time Frame: Baseline, 1-hour, 2-hours, 6-hours, 24-hours, and 48-hours post-ingestion of Plan B/placebo.
Measured in pg/mL from platelet-poor plasma using an enzyme-linked immunosorbent assay (ELISA).
P-Selectin
Time Frame: Baseline, 1-hour, 2-hours, 6-hours, 24-hours, and 48-hours post-ingestion of Plan B/placebo.
Measured in pg/mL from platelet-poor plasma using an enzyme-linked immunosorbent assay (ELISA).
Secondary Outcomes
- Weight(Baseline)
- Height(Baseline)
- Brachial artery flow-mediated dilation(Baseline, 1-hour, 2-hours, 3-hours, 4-hours, 5-hours, 6-hours, 24-hours and 48-hours post-ingestion of Plan B/placebo)
- Levonorgestrel(1-hour, 2-hours, 3-hours, 4-hours, 5-hours, 6-hours, 24-hours and 48-hours post-ingestion of Plan B/placebo)
- Systolic blood pressure(Baseline, 1-hour, 2-hours, 3-hours, 4-hours, 5-hours, 6-hours, 24-hours and 48-hours post-ingestion of Plan B/placebo)
- Diastolic blood pressure(Baseline, 1-hour, 2-hours, 3-hours, 4-hours, 5-hours, 6-hours, 24-hours and 48-hours post-ingestion of Plan B/placebo)
- Mean arterial pressure(Baseline, 1-hour, 2-hours, 3-hours, 4-hours, 5-hours, 6-hours, 24-hours and 48-hours post-ingestion of Plan B/placebo)
- Heart rate(Baseline, 1-hour, 2-hours, 3-hours, 4-hours, 5-hours, 6-hours, 24-hours and 48-hours post-ingestion of Plan B/placebo)
- Body mass index(Baseline)