Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding

Menstrual Cycle and Uterine Bleeding Disorders Clinical Trial

Official title:

Estradiol Versus Tranexamic Acid on the Amount and Duration of Acute Cyclic Heavy Menstrual Bleeding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01659008
• Other study ID #: 12-01-FB-0003
• Status: Recruiting
• Phase: N/A
• First received: August 3, 2012
• Last updated: February 13, 2015
• Start date: June 2012
• Est. completion date: March 2016

Study information

• Verified date: February 2015
• Source: Eastern Virginia Medical School
• Contact: Kay I Waud, MD PhD
• Phone: 3103820090
• Email: waudk[@]evms.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemorrhage
• Hemostatic Disorders
• Menorrhagia
• Menstrual Cycle and Uterine Bleeding Disorders
• Uterine Hemorrhage

Intervention

Drug:
• Estradiol

• Lysteda

Locations

Country	Name	City	State
United States	Jones Institue Clinical Research Center	Norfolk	Virginia
United States	Sentara Norfolk General Emergency Department	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Kay I Waud MD PhD	American College of Obstetricians and Gynecologists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	menstrual blood loss	reduction in mean menstrual blood loss in both treatment groups	48 hours	No
Secondary	changes in local hemostatic factors	changes in local, endometrial hemostatic factors in both treatment groups	48 hours	No