Testing Plan B (Levonorgestrel) against a placebo for female
Official title: The Influence of Plan B® on Cardiovascular Health.
The Influence of a Single Dose of Emergency Contraception on Markers of Venous Thrombosis and Vascular Function in Young, Healthy Females.
- 2 groups
- One site, in Hamilton
- Recruiting
Interventions
- Medication
Plan B (Levonorgestrel)
1 x dose of 1.5 mg levonorgestrel tablet over encapsulated to mimic placebo.
- Other intervention
Placebo (gelatin capsule)
Gelatin capsule over encapsulated to mimic Plan B
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Vascular Dynamics Lab
Hamilton, Ontario
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +18 - 35 years of age.
- +Eumenorrheic (i.e., experiencing a predictable menstrual cycle lasting 21-45 days).
- +Provide written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Pre-menopausal female.
- +In the surrounding Hamilton area, or able to visit McMaster for study visits.
- +Naturally cycling (i.e., not using any form of hormonal contraception for ≥ 3 months).
- +Not pregnant.
Exclusion
- −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 placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → capsule.
- −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 pharmacokineticPharmacokineticsThe study of how the body absorbs, distributes, and clears a treatment.Read more → or pharmacodynamic characteristics of the study intervention.
- −Known, suspected, or history of cardiovascular, metabolic, or musculoskeletal disease.
- −Undiagnosed abnormal vaginal bleeding.
- −Active or history of migraine.
- −A condition or factor that would prevent the use of Plan B®.
- −Known or suspected pregnancy.
- −At risk of the development of unwanted pregnancy within the past 72 hours.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is investigating how something functions in the body, rather than testing a treatment directly.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Plan B (Levonorgestrel).
Registry label: A: Plan B®
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo (gelatin capsule).
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 35 years.
The study lists female participants only.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 40 people.
The study is currently expected to finish around September 2027.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 1-hour, 2-hours, 3-hours, 4-hours, 5-hours, 6-hours, 24-hours and 48-hours post-ingestion of Plan B/placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
D-Dimer — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 1-hour, 2-hours, 3-hours, 4-hours, 5-hours, 6-hours, 24-hours and 48-hours post-ingestion of Plan B/placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
Prothrombin fragment 1+2 — measured over Baseline, 1-hour, 2-hours, 6-hours, 24-hours, and 48-hours post-ingestion of Plan B/placebo.
Thrombin antithrombin — measured over Baseline, 1-hour, 2-hours, 6-hours, 24-hours, and 48-hours post-ingestion of Plan B/placebo.
P-Selectin — measured over Baseline, 1-hour, 2-hours, 6-hours, 24-hours, and 48-hours post-ingestion of Plan B/placebo.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07759635 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Plan B (Levonorgestrel)Drug
1 x dose of 1.5 mg levonorgestrel tablet over encapsulated to mimic placebo.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo (gelatin capsule)Other
Gelatin capsule over encapsulated to mimic Plan B
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 35 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 35 years.
It lists female participants only.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 1-hour, 2-hours, 3-hours, 4-hours, 5-hours, 6-hours, 24-hours and 48-hours post-ingestion of Plan B/placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
The study as a whole is currently expected to finish around 2027-09-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 40 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Hamilton, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.