Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding
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Purpose
| 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 |
- menstrual blood loss [ Time Frame: 48 hours ] [ Designated as safety issue: No ]reduction in mean menstrual blood loss in both treatment groups
- 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 (Adult) |
| Genders 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01659008
| Contact: Kay I Waud, MD PhD | 3103820090 | waudk@evms.edu | |
| Contact: David F Archer, MD | 7574467444 | archerdf@evms.edu |
| 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 | |
| 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 |
| 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 Hemorrhage Menorrhagia Blood Coagulation Disorders Hemostatic Disorders Pathologic Processes Uterine Diseases Genital Diseases, Female Menstruation Disturbances Hematologic Diseases Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders Estradiol Polyestradiol phosphate |
Estradiol 3-benzoate Estradiol 17 beta-cypionate Estradiol valerate Tranexamic Acid Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics |
ClinicalTrials.gov processed this record on September 29, 2016