Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Estradiol Versus Tranexamic Acid on the Amount and Duration of Acute Cyclic Heavy Menstrual Bleeding|
- menstrual blood loss [ Time Frame: 48 hours ] [ Designated as safety issue: No ]reduction in mean menstrual blood loss in both treatment groups
- changes in local hemostatic factors [ Time Frame: 48 hours ] [ Designated as safety issue: No ]changes in local, endometrial hemostatic factors in both treatment groups
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
estradiol PO 0.5mg 2 tabs three times a day for 2 days
Lysteda 650mg PO 2 tabs three times a day for 2 days
BACKGROUND: The acute onset of Heavy Menstrual Bleeding (HMB) during menses results in women seeking care in the Emergency Department. The current management of HMB among our residents uses combination oral contraceptives or oral progestins. The residents in the Emergency Department often send women home without any therapeutic intervention. There is no Regulatory Agency approved therapy for acute HMB. The etiology of HMB is not well understood. Two potential causes are changes in endometrial prostaglandins and increased fibrinolytic activity in the endometrium.
Specific Aim 1 is to investigate and compare the effect of oral estradiol compared to tranexamic acid in reducing blood loss and the duration of bleeding during an acute episode HMB.
Specific Aim 2 is to evaluate the effect of estradiol and tranexamic acid on possible causes of the acute HMB by measuring prostaglandins and Plasminogen activator in menstrual effluent at the end of treatment.
METHODS: This is a randomized, double-blind, controlled, parallel-group, non-inferiority trial, with participants between the ages 18 and 45 years, with acute cyclic heavy menstrual bleeding enrolled during an emergency room visit. Participants are randomized to receive 48 hours' treatment with 1.3 mg oral tranexamic acid or 1.0 mg oral estradiol three times a day. The primary endpoint is reduction in the amount of menstrual effluent. Sample size was calculated based on detecting less than 30 ml difference between the mean menstrual blood loss of the two treatment groups. Amount of blood loss is quantified by alkaline hematin method on extraction of menstrual pads and tampons. Secondary outcome is the variation of hemostatic factors in the menstrual effluent in two treatment groups by collecting menstrual effluent and quantitating prostaglandins, Plasminogen activators, Plasminogen activator inhibitors, and vascular endothelial growth factor.
ANTICIPATED OUTCOMES: The investigators anticipate a reduction in mean menstrual blood loss in both treatment groups. Compared with participants treated with estradiol, the group treated with tranexamic acid will not have statistically significant change in reduction of menstrual effluent. We also anticipate changes in different local hemostatic factors in menstrual effluent specific to the treatment arm.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659008
|Contact: Kay I Waud, MD PhDfirstname.lastname@example.org|
|Contact: David F Archer, MDemail@example.com|
|United States, Virginia|
|Jones Institue Clinical Research Center||Recruiting|
|Norfolk, Virginia, United States, 23507|
|Contact: David F Archer, MD 757-446-7444 firstname.lastname@example.org|
|Contact: Kay I Waud, MD PhD 3103820090 email@example.com|
|Principal Investigator: Kay I Waud, MD PhD|
|Sentara Norfolk General Emergency Department||Recruiting|
|Norfolk, Virginia, United States, 23507|
|Contact: Micheal Bono, MD 757-388-4000 firstname.lastname@example.org|
|Sub-Investigator: Micheal Bono, MD|
|Principal Investigator:||Kay I Waud, MD PhD||Eastern Virginia Medical School department of obstetrics and gynecology|