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Clotting Factors Analysis for Heavy Menstrual Bleeding
Phase 1 & 2
Recruiting
Research Sponsored by Oregon Health and Science 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 enrollment to 60 days
Awards & highlights
Study Summary
This trial investigates the role of clotting factors in menstrual bleeding, looking for differences between those with heavy and regular periods.
Who is the study for?
This trial is for menstruating individuals aged 18-45 who experience heavy menstrual bleeding. It aims to understand the role of certain proteins and cells in period bleeding by comparing them with those from individuals without heavy periods.Check my eligibility
What is being tested?
The study involves collecting samples and performing an endometrial biopsy to analyze blood clotting factor proteins like PAI-1, tPA, TFPI, and how they interact with cells called HEECs during menstrual bleeding.See study design
What are the potential side effects?
Potential side effects may include discomfort or pain at the biopsy site, light spotting or bleeding post-procedure, and rare risks associated with biopsies such as infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment to 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment to 60 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the numerical score of Pictorial Blood Loss Assessment
Total number of mRNA copies from HEEC culture of PAI-1
Total number of mRNA copies from HEEC culture of TFPI
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Heavy Menstrual BleedingActive Control1 Intervention
Participants with heavy menstrual bleeding will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture.
Group II: Regular Mensural BleedingActive Control1 Intervention
Participants with normal menstrual bleeding will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
974 Previous Clinical Trials
7,385,842 Total Patients Enrolled
1 Trials studying Heavy Menstrual Bleeding
300 Patients Enrolled for Heavy Menstrual Bleeding
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a diagnosed condition causing heavy menstrual bleeding.I am willing to abstain from sex for two weeks before my biopsy.I have a bleeding disorder or I'm on blood thinners.I am between 18-45 years old and have regular menstrual cycles.I am taking medication to prevent excessive bleeding.I cannot complete a bleeding assessment chart.
Research Study Groups:
This trial has the following groups:- Group 1: Heavy Menstrual Bleeding
- Group 2: Regular Mensural Bleeding
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial available to adults aged 18 and above?
"According to the requirements for participation, potential patients must fall between 18 and 45 years of age."
Answered by AI
What do researchers look for when selecting participants in this research project?
"This clinical trial seeks to recruit approximately 70 individuals within the age range of 18 and 45 who are experiencing heavy menstrual bleeding."
Answered by AI
Is enrollment still possible for this research project?
"The clinical trial in question, as reported by clinicialtrials.gov, is no longer recruiting patients; the posting date was May 1st 2023 and it had been last updated on 8th of that same month. Nevertheless, there are 18 other trials engaging with potential participants at this time."
Answered by AI
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