Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding

Sponsor

Kay I Waud MD PhD (Other)

Overall Status

Unknown status

CT.gov ID

NCT01659008

Collaborator

American College of Obstetricians and Gynecologists (Other)

100

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Mar 1, 2016

Arms and Interventions

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

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

Primary Outcome Measures

menstrual blood loss [48 hours]
reduction in mean menstrual blood loss in both treatment groups

Secondary Outcome Measures

changes in local hemostatic factors [48 hours]
changes in local, endometrial hemostatic factors in both treatment groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Jones Institue Clinical Research Center	Norfolk	Virginia	United States	23507
2	Sentara Norfolk General Emergency Department	Norfolk	Virginia	United States	23507