Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding

Study Description

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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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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

Eligibility Criteria

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

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Kay I Waud, MD PhD	3103820090	waudk@evms.edu
Contact: David F Archer, MD	7574467444	archerdf@evms.edu

Locations

United States, Virginia
Jones Institue Clinical Research Center	Recruiting
Norfolk, Virginia, United States, 23507
Contact: David F Archer, MD 757-446-7444 archerdf@evms.edu
Contact: Kay I Waud, MD PhD 3103820090 waduk@evms.edu
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 m.bono@charter.net
Sub-Investigator: Micheal Bono, MD

Sponsors and Collaborators

Kay I Waud MD PhD

American College of Obstetricians and Gynecologists

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Kay I Waud MD PhD, principal investigator, FELLOW physician PGY6, Eastern Virginia Medical School
ClinicalTrials.gov Identifier:	NCT01659008 History of Changes
Other Study ID Numbers:	12-01-FB-0003
First Posted:	August 7, 2012
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:

Hemorrhage; Blood Coagulation Disorders; Hemostatic Disorders; Uterine Hemorrhage; Menorrhagia; Pathologic Processes; Hematologic Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Uterine Diseases; Genital Diseases, Female; Menstruation Disturbances; Estradiol; Polyestradiol phosphate	Estradiol 3-benzoate; Estradiol 17 beta-cypionate; Estradiol valerate; Tranexamic Acid; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics