Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding
Estradiol Versus Tranexamic Acid on the Amount and Duration of Acute Cyclic Heavy Menstrual Bleeding
1 other identifier
interventional
100
1 country
2
Brief Summary
Treatment with Estradiol is non-inferior to treatment with Tranexamic acid in reducing the amount and duration of menstrual blood loss in women with cyclic heavy menstrual bleeding
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 3, 2012
CompletedFirst Posted
Study publicly available on registry
August 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFebruary 16, 2015
February 1, 2015
3.5 years
August 3, 2012
February 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
menstrual blood loss
reduction in mean menstrual blood loss in both treatment groups
48 hours
Secondary Outcomes (1)
changes in local hemostatic factors
48 hours
Study Arms (2)
estradiol
EXPERIMENTALestradiol PO 0.5mg 2 tabs three times a day for 2 days
Lysteda
EXPERIMENTALLysteda 650mg PO 2 tabs three times a day for 2 days
Interventions
Eligibility Criteria
You may qualify if:
- Age: between 18-45 years old
- Hemoglobin concentration: less than or equal to 11.5 g/dL, greater than or equal to 8.0 g/dL
- BMI: less than or equal to 35
- Menstrual cycle: previous menstrual cycle interval between 26 to 34 days with less than or equal to 10 days of bleeding
- Contraception: at least two months from implant removal, or six months from their last depo-provera or depo-Lupron injection, or recently(at least 2 months) discontinued oral, patch or intravaginal ring contraceptives
- On cycle day 1-3 of the current menstrual bleeding episode
You may not qualify if:
- NSAID, or aspirin containing medications during the 48 hours preceding the current ER visit
- Estrogen or progestin treatment during the 30 days preceding the current ER visit
- Using Paraguard
- Pregnant and or lactating
- History of endometrial ablation
- Women with thromboembolic disease, or coagulopathy
- Women with history of myocardial infarction, or cerebrovascular occlusion
- Uncontrolled high blood pressure (blood pressure greater than 150/90)
- Sensitivity to estrogen, or tranexamic acid
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jones Institue Clinical Research Center
Norfolk, Virginia, 23507, United States
Sentara Norfolk General Emergency Department
Norfolk, Virginia, 23507, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kay I Waud, MD PhD
Eastern Virginia Medical School department of obstetrics and gynecology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- principal investigator, FELLOW physician PGY6
Study Record Dates
First Submitted
August 3, 2012
First Posted
August 7, 2012
Study Start
June 1, 2012
Primary Completion
December 1, 2015
Study Completion
March 1, 2016
Last Updated
February 16, 2015
Record last verified: 2015-02