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Prostaglandin E1 Analog
Misoprostol for Uterine Fibroids
Phase 4
Waitlist Available
Led By Magdy Milad, MD
Research Sponsored by Northwestern 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 intra-operative
Awards & highlights
Study Summary
This trial is testing whether a single dose of the medication misoprostol, taken by mouth, can reduce blood loss during surgery to remove fibroid tumors from the uterus.
Eligible Conditions
- Uterine Fibroids
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of surgery completion through discharge from hospital, an expected average period of 3 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of surgery completion through discharge from hospital, an expected average period of 3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Estimated Intra-operative Blood Loss
Secondary outcome measures
Duration of Procedure
Length of Inpatient Hospitalization
Post-operative Blood Transfusion
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MisoprostolExperimental Treatment1 Intervention
25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.
Group II: PlaceboPlacebo Group1 Intervention
25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Misoprostol
2008
Completed Phase 4
~3340
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,586 Previous Clinical Trials
917,204 Total Patients Enrolled
Magdy Milad, MDPrincipal Investigator - Northwestern University, Northwestern Memorial Hopsital
Central DuPage Hospital, Northwestern Lake Forest Hospital, Northwestern Memorial Hospital
Wayne State University School Of Medicine (Medical School)
Mayo Grad School Med/Mayo Fndn (Residency)
3 Previous Clinical Trials
254 Total Patients Enrolled
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