Plan B for Cardiovascular Health
(LEVOH Trial)
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Mark Crowther, MD, MSc, LLM, FRCPC, FRSC
Principal Investigator
McMaster University
Maureen J MacDonald, PhD
Principal Investigator
McMaster University
Are You a Good Fit for This Trial?
This trial is for healthy, premenopausal women who have not gone through menopause. Participants should not have a history of blood clots or other major health issues that could affect the study results.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline measurements of venous thrombosis markers, blood pressure, and measures of arterial function using ultrasound
Treatment
Participants are randomized to take a single dose of Plan B® or placebo, followed by repeated measurements of cardiovascular markers
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Levonorgestrel
Trial Overview
The study compares the effects of a single dose of Plan B® (levonorgestrel) to a placebo pill on heart and blood vessel health. It uses random assignment and neither participants nor researchers know which pill is given.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
1.5 mg Levonorgestrel
Gelatin capsule
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.