Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kay I Waud MD PhD
• Collaborator: American College of Obstetricians and Gynecologists
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate; Tranexamic Acid

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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