Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding

This study is currently recruiting participants.
Verified August 2012 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: August 6, 2012
Last verified: August 2012
  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:


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: June 2013
Estimated Primary Completion Date: June 2013 (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
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
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         
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         
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, resident physician PGY4, 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: August 6, 2012
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
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Menorrhagia
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Tranexamic Acid
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Antifibrinolytic Agents
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on April 16, 2014