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The Influence of Plan B® on Cardiovascular Health.

NCT07759635 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-12

No results posted yet for this study

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:

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.

Conditions

  • Female
  • Premenopausal

Interventions

DRUG

Plan B (Levonorgestrel)

1 x dose of 1.5 mg levonorgestrel tablet over encapsulated to mimic placebo.

OTHER

Placebo (gelatin capsule)

Gelatin capsule over encapsulated to mimic Plan B

Sponsors & Collaborators

Principal Investigators

  • Mark Crowther, MD, MSc, LLM, FRCPC, FRSC · McMaster University

  • Maureen J MacDonald, PhD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-22
Primary Completion
2027-06-01
Completion
2027-09-01

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07759635 on ClinicalTrials.gov