Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2015 by Eastern Virginia Medical School

Sponsor:

Collaborator:

American College of Obstetricians and Gynecologists

Information provided by (Responsible Party):

Kay I Waud MD PhD, Eastern Virginia Medical School

ClinicalTrials.gov Identifier:

NCT01659008

First received: August 3, 2012

Last updated: February 13, 2015

Last verified: February 2015

History of Changes

Purpose

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	Intervention
Menstrual Cycle and Uterine Bleeding Disorders	Drug: Estradiol Drug: Lysteda


Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Bleeding Menstruation

Drug Information available for: Estradiol Estradiol cypionate Estradiol valerate Tranexamic acid Estradiol acetate Estradiol hemihydrate

U.S. FDA Resources

Further study details as provided by Eastern Virginia Medical School:

Primary Outcome Measures:

menstrual blood loss [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
reduction in mean menstrual blood loss in both treatment groups

Secondary Outcome Measures:

changes in local hemostatic factors [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
changes in local, endometrial hemostatic factors in both treatment groups


Estimated Enrollment:	100
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)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 45 Years
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659008

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

No publications provided


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
Study First Received:	August 3, 2012
Last Updated:	February 13, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by Eastern Virginia Medical School:


acute cyclical heavy menstrual bleeding

Additional relevant MeSH terms:


Uterine Hemorrhage Menorrhagia Genital Diseases, Female Menstruation Disturbances Pathologic Processes Uterine Diseases Estradiol Estradiol 17 beta-cypionate Estradiol 3-benzoate Estradiol valerate	Polyestradiol phosphate Contraceptive Agents Contraceptive Agents, Female Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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