96 Participants Needed

Aspirin for Endometriosis

LA
SS
Overseen BySue Slimak, RN
Age: 18 - 65
Sex: Female
Trial Phase: Phase 4
Sponsor: Penn State University
Must be taking: Aspirin
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to compare neurovascular regulation in women with endometriosis and healthy women. The main questions it aims to answer are:* Do women with endometriosis have greater blood pressure and pain responses to a stimulus than healthy women?* Do women with endometriosis have greater platelet activity than healthy women?Participants will take aspirin and/or placebo and will:* perform hand grip exercise and cold pressor tests* undergo iontophoresis and blood drawResearchers will compare women with and without endometriosis to see if there is a difference in neurovascular regulation.

Will I have to stop taking my current medications?

The trial requires that you stop taking any current medications that could affect cardiovascular responses, such as blood pressure medications or diuretics.

Is aspirin generally safe for humans?

Aspirin, also known as acetylsalicylic acid, is widely used and generally considered safe for most people when taken as directed. It is commonly used to relieve pain and reduce inflammation, but like any medication, it can have side effects, such as stomach upset or increased bleeding risk, especially at higher doses.12345

How does the drug aspirin differ from other treatments for endometriosis?

Aspirin is unique in its potential use for endometriosis due to its anti-inflammatory and antiplatelet properties, which are well-documented in other conditions like cardiovascular diseases and preeclampsia. Unlike standard endometriosis treatments, aspirin's ability to inhibit platelet aggregation and reduce inflammation might offer a novel approach to managing symptoms.678910

What evidence supports the effectiveness of aspirin as a drug for endometriosis?

Aspirin is known for its pain-relieving and anti-inflammatory effects, which may help with endometriosis symptoms. It has been used effectively in other conditions like preeclampsia and coronary artery disease, suggesting potential benefits for endometriosis.6781011

Are You a Good Fit for This Trial?

This trial is for women aged 18-45, with or without endometriosis. It's not suitable for those who are pregnant, breastfeeding, have a high BMI or certain health conditions like cardiovascular disease, diabetes, severe liver or kidney issues, hypertension/hypotension, Raynaud's syndrome; those on medications affecting blood pressure; smokers; recent hormone therapy users; and individuals with skin allergies.

Inclusion Criteria

I was born with a uterus.
With and without endometriosis

Exclusion Criteria

Currently pregnant or breastfeeding
Allergy or hypersensitivity to investigational agents
I have been diagnosed with a heart condition.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of aspirin or placebo and perform hand grip exercise and cold pressor tests, undergo iontophoresis and blood draw

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Aspirin
  • Placebo
Trial Overview The study tests how aspirin affects blood pressure and pain in response to stress in women with endometriosis compared to healthy women. Participants will take aspirin or a placebo and undergo exercises and tests to measure neurovascular regulation differences between the two groups.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AspirinExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Aspirin is already approved in European Union, United States, Canada, China for the following indications:

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Approved in European Union as Aspirin for:
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Approved in United States as Aspirin for:
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Approved in Canada as Aspirin for:
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Approved in China as Aspirin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials
380
Recruited
131,000+

Published Research Related to This Trial

Aspirin (ASA) significantly inhibits the growth of endometrial cancer cells (Ishikawa cells) in vitro, with growth inhibition ranging from 21% to 88% at concentrations of 1-5 mM over 96 hours.
The mechanism of action includes inducing apoptosis and reducing bcl-2 expression, with higher concentrations of ASA leading to increased apoptosis and a shift in the cell cycle from the resting phase to the S phase.
Aspirin effects on endometrial cancer cell growth.Arango, HA., Icely, S., Roberts, WS., et al.[2019]
A systematic review of studies indicates that low-dose aspirin (80-150 mg daily) taken in the first trimester (before 16 weeks) may effectively reduce the severity of preeclampsia in at-risk pregnancies.
In contrast, studies administering aspirin later in pregnancy showed mixed results, suggesting that the timing and dosage of aspirin are crucial for its effectiveness in preventing preeclampsia.
[The Role of Aspirin in Preeclampsia Prevention: State of the Art].Campos, A.[2018]
Aspirin is considered safe for use during pregnancy at daily doses not exceeding 100mg and has been shown to effectively prevent pre-eclampsia and fetal growth restriction in high-risk patients.
However, aspirin has not demonstrated benefits for preventing vascular placental disease in low-risk patients or for unexplained recurrent miscarriages.
[Aspirin: Indications and use during pregnancy].Belhomme, N., Doudnikoff, C., Polard, E., et al.[2018]

Citations

Aspirin effects on endometrial cancer cell growth. [2019]
[The Role of Aspirin in Preeclampsia Prevention: State of the Art]. [2018]
[Aspirin: Indications and use during pregnancy]. [2018]
The effect of aspirin on bleeding after extraction of teeth. [2022]
Effect of Sustained Use of Aspirin until the Time of Surgery on Outcomes following Coronary Artery Bypass Grafting: A Randomized Clinical Trial. [2018]
Evaluation of peritoneal endometriosis treatment using intralesional acetylsalicylic acid injection in rabbits. [2019]
Low-dose aspirin can downregulate progesterone resistance and increase the expression of LIF in endometriosis during the implantation window. [2022]
Non-steroidal anti-inflammatory drugs increase MRP4 expression in an endometriotic epithelial cell line in a PPARa dependent manner. [2019]
Effects of a selective cyclooxygenase-2 inhibitor on endometrial epithelial cells from patients with endometriosis. [2019]
Suppressive Effects of Ursolic Acid on Human Endometriotic Stromal Cells Survival. [2023]
[Acetylsalicylic acid in the treatment of cardiovascular and cerebrovascular diseases]. [2013]
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