Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding

NCT ID: NCT01659008

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-03-31

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

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.

Conditions

Menstrual Cycle and Uterine Bleeding Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

estradiol

estradiol PO 0.5mg 2 tabs three times a day for 2 days

Group Type: EXPERIMENTAL

Estradiol

Intervention Type: DRUG

Lysteda

Lysteda 650mg PO 2 tabs three times a day for 2 days

Group Type: EXPERIMENTAL

Lysteda

Intervention Type: DRUG

Interventions

Estradiol

Intervention Type: DRUG

Lysteda

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

American College of Obstetricians and Gynecologists

OTHER

Sponsor Role: collaborator

Kay I Waud MD PhD

OTHER

Sponsor Role: lead

Responsible Party

Kay I Waud MD PhD

principal investigator, FELLOW physician PGY6

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kay I Waud, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical School department of obstetrics and gynecology

Locations

Jones Institue Clinical Research Center

Norfolk, Virginia, United States

Site Status: RECRUITING

Sentara Norfolk General Emergency Department

Norfolk, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kay I Waud, MD PhD

Role: CONTACT

waudk@evms.edu

3103820090

David F Archer, MD

Role: CONTACT

archerdf@evms.edu

7574467444

Facility Contacts

David F Archer, MD

Role: primary

archerdf@evms.edu

757-446-7444

Kay I Waud, MD PhD

Role: backup

waduk@evms.edu

3103820090

Micheal Bono, MD

Role: primary

m.bono@charter.net

757-388-4000

Other Identifiers

12-01-FB-0003

Identifier Type: -

Identifier Source: org_study_id