Female, Premenopausal
Conditions
Keywords
Emergency contraceptives, Hormonal contraceptives, Venous thrombosis, Endothelial function
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: 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.
Interventions
1 x dose of 1.5 mg levonorgestrel tablet over encapsulated to mimic placebo.
OTHERPlacebo (gelatin capsule)
Gelatin capsule over encapsulated to mimic Plan B
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provide written informed consent. 2. Pre-menopausal female. 3. 18 - 35 years of age. 4. Naturally cycling (i.e., not using any form of hormonal contraception for ≥ 3 months). 5. Eumenorrheic (i.e., experiencing a predictable menstrual cycle lasting 21-45 days). 6. In the surrounding Hamilton area, or able to visit McMaster for study visits. 7. Not pregnant.
Exclusion criteria
1. 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. 2. Known or suspected pregnancy. 3. At risk of the development of unwanted pregnancy within the past 72 hours. 4. Known, suspected, or history of cardiovascular, metabolic, or musculoskeletal disease. 5. Undiagnosed abnormal vaginal bleeding. 6. 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. 7. Active or history of migraine. 8. A condition or factor that would prevent the use of Plan B®.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| D-Dimer | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Measured as the percent change in brachial artery diameter from baseline to peak dilation following reactive hyperemia (%FMD). |
| Levonorgestrel | 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 pg/mL from serum using an enzyme-linked immunosorbent assay (ELISA). |
| 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 | Measured in millimeters of mercury (mmHg) |
| 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 | Measured in millimeters of mercury (mmHg) |
| 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 | Measured in millimeters of mercury (mmHg) |
| 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 | Measured in beats per minute (bpm). |
| Height | Baseline | Measured in cm using a standiometer |
| Weight | Baseline | Measured in kg using a weight scale |
| Body mass index | Baseline | weight (kg) / ( height (m) )\^2 |
Countries
Canada
Contacts
CONTACTJenna C Stone, BSc
PRINCIPAL_INVESTIGATORMark Crowther, MD, MSc, LLM, FRCPC, FRSC
McMaster University
PRINCIPAL_INVESTIGATORMaureen J MacDonald, PhD
McMaster University
Outcome results
None listed