Aspirin for Endometriosis
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Penn State University
Must be taking: Aspirin
Must not be taking: Antihypertensives, Diuretics, Digoxin
Disqualifiers: Cardiovascular disease, Diabetes, Hypertension, others
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
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 draw
Researchers 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.
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.
12345Is 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.
678910How 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.
123411Eligibility Criteria
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 am between 18 and 45 years old.
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.
+12 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AspirinExperimental Treatment1 Intervention
one dose of aspirin
Group II: PlaceboPlacebo Group1 Intervention
Placebo pill
Aspirin is already approved in European Union, United States, Canada, China for the following indications:
🇪🇺 Approved in European Union as Aspirin for:
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
- Preeclampsia prevention
🇺🇸 Approved in United States as Aspirin for:
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
- Preeclampsia prevention
🇨🇦 Approved in Canada as Aspirin for:
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
- Preeclampsia prevention
🇨🇳 Approved in China as Aspirin for:
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Noll LaboratoryUniversity Park, PA
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Who Is Running the Clinical Trial?
Penn State UniversityLead Sponsor
References
Aspirin effects on endometrial cancer cell growth. [2019]To find whether aspirin (acetylsalicylic acid, ASA) inhibits the growth of endometrial cancer cells in vitro in a way similar to that in colorectal cancer cells and to investigate the mechanisms by which aspirin might lead to growth inhibition.
[The Role of Aspirin in Preeclampsia Prevention: State of the Art]. [2018]The role of acetyl salicylic acid (ASA or aspirin) in preeclampsia prevention and in other complications has been subject to studies and controversies for the last 30 years. The first research results concerning the role of placenta in preeclampsia have been published by the end of seventies and they showed an increase in the platelet activity and a prostaglandin synthesis disturbance, as a consequence of a deficient placentation. In the last twenty years of the XX century important studies were published on the aspirinprophylactic role in preeclampsia risk reduction.
[Aspirin: Indications and use during pregnancy]. [2018]Aspirin (acetylsalicylic acid) has been used ever since the Antiquity for its painkilling and anti-inflammatory effects. Its antiplatelet properties have then extended its indications to the field of coronaropathy and vascular cerebral disease, and finally to vascular placental disease. Aspirin has been widely prescribed since the 1980's to prevent pre-eclampsia, intra-uterine growth retardation and fetal death of vascular origin. It has also been proposed to prevent unexplained recurrent miscarriages. Its use during pregnancy is considered as safe, provided the daily doses do not exceed 100mg. Aspirin has been proven efficient to prevent pre-eclampsia and fetal growth restriction in high-risk patients. The benefits of prescribing aspirin have been demonstrated neither for vascular placental disease prevention in low risk patients, nor in cases of unexplained recurrent miscarriages.
The effect of aspirin on bleeding after extraction of teeth. [2022]Acetylsalicylic acid (ASA) generically known as aspirin is used clinically as an analgesic, antipyretic, anti-inflammatory and as a medication to prevent platelet aggregation. Many studies have investigated bleeding associated with ASA.
Effect of Sustained Use of Aspirin until the Time of Surgery on Outcomes following Coronary Artery Bypass Grafting: A Randomized Clinical Trial. [2018]The topic of aspirin (acetylsalicylic acid, ASA) use in coronary artery disease patients planned for coronary artery bypass grafting during perioperative period is among the most disputed issues in cardiac surgery. We designed a study to weigh the risks and benefits of continued ASA ingestion until the time of surgery.
Evaluation of peritoneal endometriosis treatment using intralesional acetylsalicylic acid injection in rabbits. [2019]To investigate the efficacy of intralesional 20% aspirin injection for treatment of experimental peritoneal endometriosis.
Low-dose aspirin can downregulate progesterone resistance and increase the expression of LIF in endometriosis during the implantation window. [2022]Study the effect of low-dose aspirin on the endometrial receptivity in endometriosis rat models.
Non-steroidal anti-inflammatory drugs increase MRP4 expression in an endometriotic epithelial cell line in a PPARa dependent manner. [2019]Endometriosis is a debilitating disease characterized by chronic inflammation. The transporter multidrug resistance-associated protein 4 (MRP4/ABCC4) is expressed in human endometrial tissue; it is overexpressed in ectopic endometrial tissue, and is modulated by the anti-inflammatory lipid Lipoxin A4 (LXA4). Recently, it was demonstrated that aspirin induces platelet MRP4 over-expression, through genomic modulation in megakaryocytes. Since patients with endometriosis frequently use aspirin or other non-aspirin Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), the aim of this study was to verify whether aspirin and other NSAIDs enhance MRP4 expression in 12Z human endometriotic epithelial cells and whether this was peroxisome proliferator-activated receptor alpha (PPARa) dependent.
Effects of a selective cyclooxygenase-2 inhibitor on endometrial epithelial cells from patients with endometriosis. [2019]Celecoxib, a selective cyclooxygenase (COX)-2 inhibitor, also has anti-proliferative properties and pro-apoptotic effects on different in vivo and in vitro models, two actions that may be efficacious in therapy for endometriosis. We evaluated the effects of celecoxib on apoptosis and proliferation, and vascular endothelial growth factor (VEGF) production and COX-2 expression and activity in endometrial epithelial cells (EECs).
Suppressive Effects of Ursolic Acid on Human Endometriotic Stromal Cells Survival. [2023]The identification of new compound candidates for endometriosis treatment is needed. Cyclooxygenase-2 (COX-2) is considered a crucial target to control the progress and recurrence of endometriosis. Here, we identified ursolic acid (UA) as a natural inhibitor of COX-2 and investigated its effects on endometriosis progression.
[Acetylsalicylic acid in the treatment of cardiovascular and cerebrovascular diseases]. [2013]This year acetylsalicylic acid (aspirin) celebrates its 100-year anniversary. While the drug was previously used mainly as an antipyretic and a pain-killer, aspirin has, during the last 10-15 years, become one of the most important agents in the treatment of cardiovascular and cerebrovascular diseases. In addition to being one of our oldest drugs, aspirin is one of the most interesting and widely used remedies. The antithrombotic property of aspirin is mainly related to its irreversible inhibition of the production of platelet-derived thromboxane A2, which possesses aggregatory and vasoconstrictive properties. Aspirin reduces the risk in patients with overt cardiovascular and cerebrovascular diseases, i.e. chronic stable and unstable angina pectoris. It also reduces the risk in the acute phase of and following a myocardial infarction and after a transient ischemic attack or stroke. The use of the drug is controversial in primary cardiovascular prevention. Overall mortality is not reduced, and side-effects, such as increased bleeding tendency, may be serious. This side-effect is dose-dependent, and smaller doses (75-160 mg) which have the same effect as higher doses should be preferred.