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Antiplatelet Agent
Aspirin for Endometriosis
Phase 4
Recruiting
Research Sponsored by Penn State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will compare blood pressure, pain, and platelet activity in women with and without endometriosis during certain tests. Participants will take aspirin and/or placebo and undergo exercise, cold pressor tests, iontophoresis, and blood draw.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Aspirin may cause side effects such as stomach upset or bleeding risks. The placebo should have no active effects but can sometimes cause reactions due to expectations of treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
blood pressure
heart rate
pain scale
+1 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AspirinExperimental Treatment1 Intervention
one dose of aspirin
Group II: PlaceboPlacebo Group1 Intervention
Placebo pill
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin
2014
Completed Phase 4
~55580
Find a Location
Who is running the clinical trial?
Penn State UniversityLead Sponsor
368 Previous Clinical Trials
127,467 Total Patients Enrolled
4 Trials studying Endometriosis
172 Patients Enrolled for Endometriosis
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