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Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01659008
Recruitment Status : Unknown
Verified February 2015 by Kay I Waud MD PhD, Eastern Virginia Medical School.
Recruitment status was:  Recruiting
First Posted : August 7, 2012
Last Update Posted : February 16, 2015
American College of Obstetricians and Gynecologists
Information provided by (Responsible Party):
Kay I Waud MD PhD, Eastern Virginia Medical School

Brief 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

Condition or disease Intervention/treatment Phase
Menstrual Cycle and Uterine Bleeding Disorders Drug: Estradiol Drug: Lysteda Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Estradiol Versus Tranexamic Acid on the Amount and Duration of Acute Cyclic Heavy Menstrual Bleeding
Study Start Date : June 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016

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

Primary Outcome Measures :
  1. menstrual blood loss [ Time Frame: 48 hours ]
    reduction in mean menstrual blood loss in both treatment groups

Secondary Outcome Measures :
  1. changes in local hemostatic factors [ Time Frame: 48 hours ]
    changes in local, endometrial hemostatic factors in both treatment groups

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01659008

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Contact: Kay I Waud, MD PhD 3103820090
Contact: David F Archer, MD 7574467444

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United States, Virginia
Jones Institue Clinical Research Center Recruiting
Norfolk, Virginia, United States, 23507
Contact: David F Archer, MD    757-446-7444   
Contact: Kay I Waud, MD PhD    3103820090   
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   
Sub-Investigator: Micheal Bono, MD         
Sponsors and Collaborators
Kay I Waud MD PhD
American College of Obstetricians and Gynecologists
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Principal Investigator: Kay I Waud, MD PhD Eastern Virginia Medical School department of obstetrics and gynecology
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Responsible Party: Kay I Waud MD PhD, principal investigator, FELLOW physician PGY6, Eastern Virginia Medical School Identifier: NCT01659008    
Other Study ID Numbers: 12-01-FB-0003
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015
Keywords provided by Kay I Waud MD PhD, Eastern Virginia Medical School:
acute cyclical heavy menstrual bleeding
Additional relevant MeSH terms:
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Uterine Hemorrhage
Hemostatic Disorders
Blood Coagulation Disorders
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Uterine Diseases
Menstruation Disturbances
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs