Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding
Status unconfirmed · Not applicable
Conditions studied: Menstrual Cycle and Uterine Bleeding Disorders
In brief
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
Key facts
- Study ID
- NCT01659008
- Run by
- Kay I Waud MD PhD
- People needed
- 100
- Starts
- 2012-06-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2015-02-16
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
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
Where it is running
- Jones Institue Clinical Research Center — Norfolk, Virginia, United States (enrolling)
- Sentara Norfolk General Emergency Department — Norfolk, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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