Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Kay I Waud MD PhD, Eastern Virginia Medical School.
Recruitment status was:  Recruiting
American College of Obstetricians and Gynecologists
Information provided by (Responsible Party):
Kay I Waud MD PhD, Eastern Virginia Medical School Identifier:
First received: August 3, 2012
Last updated: February 13, 2015
Last verified: February 2015
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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:

Further study details as provided by Kay I Waud MD PhD, Eastern Virginia Medical School:

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

Secondary Outcome Measures:
  • changes in local hemostatic factors [ Time Frame: 48 hours ]
    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.


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
  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 identifier: NCT01659008

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

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

Responsible Party: Kay I Waud MD PhD, principal investigator, FELLOW physician PGY6, Eastern Virginia Medical School Identifier: NCT01659008     History of Changes
Other Study ID Numbers: 12-01-FB-0003
Study First Received: August 3, 2012
Last Updated: February 13, 2015

Keywords provided by Kay I Waud MD PhD, Eastern Virginia Medical School:
acute cyclical heavy menstrual bleeding

Additional relevant MeSH terms:
Uterine Hemorrhage
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Menstruation Disturbances
Tranexamic Acid
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents processed this record on May 25, 2017