Menstrual Cycle and Uterine Bleeding DisordersNCT01659008
Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding
A study testing Estradiol and Lysteda in people with Menstrual Cycle and Uterine Bleeding Disorders, run by Kay I Waud MD PhD at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Menstrual Cycle and Uterine Bleeding Disorders
- What is being tested?
- Estradiol and Lysteda
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Jones Institue Clinical Research Center
Norfolk, Virginia, 23507
David F Archer, MD, 757-446-7444, archerdf@evms.edu
Kay I Waud, MD PhD, 3103820090, waduk@evms.edu
- Recruiting
Sentara Norfolk General Emergency Department
Norfolk, Virginia, 23507
Micheal Bono, MD, 757-388-4000, m.bono@charter.net
Micheal Bono, MD
About this study
Official title: Estradiol Versus Tranexamic Acid on the Amount and Duration of Acute Cyclic Heavy Menstrual Bleeding
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
Read the 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.
- Being tested
- Estradiol, Lysteda
- Keywords
- acute cyclical heavy menstrual bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstradiolDrug
LystedaDrug
| Study group | Role | What they receive |
|---|---|---|
| estradiol | Experimental | estradiol PO 0.5mg 2 tabs three times a day for 2 days Receives: Drug: Estradiol |
| Lysteda | Experimental | Lysteda 650mg PO 2 tabs three times a day for 2 days Receives: Drug: Lysteda |
What is being measured
The primary outcome is the main question the study is designed to answer.
menstrual blood loss
reduction in mean menstrual blood loss in both treatment groups
Measured: 48 hours
Secondary outcomes (1)
changes in local hemostatic factors
changes in local, endometrial hemostatic factors in both treatment groups
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual Cycle and Uterine Bleeding DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kay I Waud MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Obstetricians and Gynecologists
- Responsible party
- Sponsor-investigator, Kay I Waud MD PhD, Eastern Virginia Medical School
- Investigators
- Kay I Waud, MD PhD, Principal investigator, Eastern Virginia Medical School department of obstetrics and gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659008
- Sponsor's protocol ID
- 12-01-FB-0003
- Status last verified
- Feb 2015
- First submitted
- 3 Aug 2012
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estradiol Versus Tranexamic Acid on the Amount and Duration of Acute Cyclic Heavy Menstrual Bleeding
- ClinicalTrials.gov ID
- NCT01659008
- Acronym / sponsor ID
- 12-01-FB-0003
- Keywords
- acute cyclical heavy menstrual bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kay I Waud MD PhDUniversity, hospital or other
- Collaborators
- American College of Obstetricians and Gynecologists
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| estradiol | Experimental | Drug: Estradiolestradiol PO 0.5mg 2 tabs three times a day for 2 days |
| Lysteda | Experimental | Drug: LystedaLysteda 650mg PO 2 tabs three times a day for 2 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol | Drug | estradiol |
| Lysteda | Drug | Lysteda |
Primary outcome
menstrual blood loss
Time frame: 48 hours
reduction in mean menstrual blood loss in both treatment groups
1 secondary outcome
changes in local hemostatic factors
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kay I Waud, MD PhD principal investigator
Eastern Virginia Medical School department of obstetrics and gynecology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estradiol and Lysteda in people with Menstrual Cycle and Uterine Bleeding Disorders, run by Kay I Waud MD PhD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kay I Waud, MD PhD (3103820090, waudk@evms.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
menstrual blood loss (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.