Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding
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| ClinicalTrials.gov Identifier: NCT01659008 |
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Recruitment Status : Unknown
Verified February 2015 by Kay I Waud MD PhD, Eastern Virginia Medical School.
Recruitment status was: Recruiting
First Posted : August 7, 2012
Last Update Posted : February 16, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Menstrual Cycle and Uterine Bleeding Disorders | Drug: Estradiol Drug: Lysteda | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated 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 : | June 2012 |
| Estimated Primary Completion Date : | December 2015 |
| Estimated Study Completion Date : | March 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: estradiol
estradiol PO 0.5mg 2 tabs three times a day for 2 days
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Drug: Estradiol |
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Experimental: Lysteda
Lysteda 650mg PO 2 tabs three times a day for 2 days
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Drug: Lysteda |
- menstrual blood loss [ Time Frame: 48 hours ]reduction in mean menstrual blood loss in both treatment groups
- changes in local hemostatic factors [ Time Frame: 48 hours ]changes in local, endometrial hemostatic factors in both treatment groups
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| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| 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 |
| First Posted: | August 7, 2012 Key Record Dates |
| Last Update Posted: | February 16, 2015 |
| Last Verified: | February 2015 |
Keywords provided by Kay I Waud MD PhD, Eastern Virginia Medical School:
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acute cyclical heavy menstrual bleeding |
Additional relevant MeSH terms:
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Hemorrhage Blood Coagulation Disorders Hemostatic Disorders Uterine Hemorrhage Menorrhagia Pathologic Processes Hematologic Diseases Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders Uterine Diseases Genital Diseases, Female Menstruation Disturbances 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 |