Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding

February 13, 2015 updated by: Kay I Waud MD PhD

Estradiol Versus Tranexamic Acid on the Amount and Duration of Acute Cyclic 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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Jones Institue Clinical Research Center
        • Contact:
        • Principal Investigator:
          • Kay I Waud, MD PhD
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General Emergency Department
        • Contact:
        • Sub-Investigator:
          • Micheal Bono, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: estradiol
estradiol PO 0.5mg 2 tabs three times a day for 2 days
Drug: Estradiol
Experimental: Lysteda
Lysteda 650mg PO 2 tabs three times a day for 2 days
Drug: Lysteda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
menstrual blood loss
Time Frame: 48 hours
reduction in mean menstrual blood loss in both treatment groups
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in local hemostatic factors
Time Frame: 48 hours
changes in local, endometrial hemostatic factors in both treatment groups
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kay I Waud MD PhD

Collaborators

American College of Obstetricians and Gynecologists

Investigators

  • Principal Investigator: Kay I Waud, MD PhD, Eastern Virginia Medical School department of obstetrics and gynecology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

August 3, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimate)

August 7, 2012

Study Record Updates

Last Update Posted (Estimate)

February 16, 2015

Last Update Submitted That Met QC Criteria

February 13, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-01-FB-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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