MenorrhagiaNCT00111215
Treatment and Management of Women With Bleeding Disorders
A study testing Tranexamic Acid and Desmopressin Acetate in people with Menorrhagia and Blood Coagulation Disorders, run by Centers for Disease Control and Prevention at 6 sites in United States.
Trial summary
The purpose of the study is to determine whether oral contraceptives, desmopressin acetate, and/or tranexamic acid are effective in the treatment of women with menorrhagia who are diagnosed with a bleeding disorder. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Menorrhagia, Blood Coagulation Disorders, Blood Platelet Disorders
- What is being tested?
- Tranexamic Acid and Desmopressin Acetate
- How many people
- 100 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2001to Sep 2006
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Referred to study by gynecologist or internist/family practitioner with diagnosis of menorrhagia or referred by self through community advertising or networking
- Prospective pictorial chart scores of menses >100
- Negative pelvic exam and Pap smear within the past year. *Ultrasound if manual exam indicates abnormal uterine size; *Endometrial biopsy if >35 and non-cyclic bleeding; *Rule out acute pelvic diseases - gonorrhea, chlamydia
- Age 18-50
- Willing to go off oral contraceptives and selected drugs (including some nutritional supplements and drugs that affect coagulation such as aspirin and ibuprofen) for initial laboratory testing and throughout the cross-over drug portion of the study
- Periods at least every 39 days
Who cannot join
- Patient is not proficient in English
- Patient is pregnant
- Patient on hormone replacement, Depo-Provera, or Norplant in last three months
- Patient has intrauterine device (IUD) present
- Patient is taking warfarin sodium (Coumadin) or other anti-coagulation therapy
- History of documented vascular disease (coronary artery disease, cerebrovascular disease or stroke, transient ischemic attack, peripheral vascular disease)
Show all 13Show fewer
- Uncontrolled hypertension
- Insulin dependent diabetes mellitus
- Chronic renal or liver disease
- History of seizure disorder
- History of cancer (other than non-invasive skin cancer)
- History of venous or arterial thromboembolism
- Patient with a previously diagnosed bleeding disorder has taken or is taking desmopressin acetate or antifibrinolytic drugs for treatment of heavy menstrual bleeding
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University School of Medicine
Atlanta, Georgia, 30303
Duke University Medical Center
Durham, North Carolina, 27710
Michigan State University
East Lansing, Michigan, 48864
UMDNJ Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
The Mayo Clinic
Rochester, Minnesota, 55905
Mary M. Gooley Hemophilia Center
Rochester, New York, 14621
About this study
The purpose of the study is to determine whether oral contraceptives, desmopressin acetate, and/or tranexamic acid are effective in the treatment of women with menorrhagia who are diagnosed with a bleeding disorder.
Read the detailed description
Menorrhagia is a common clinical problem. Morbid events include dysmenorrhea, hospitalizations, red blood cell transfusions, and quality of life impairment in terms of daily activities, chronic pain, and time lost from work and or school. Up to 60% of women with uncontrolled menorrhagia undergo hysterectomy. Up to 20% of women with menorrhagia may have undiagnosed von Willebrand disease (vWd), or other bleeding disorders. Prevalence of vWd in the general population is estimated at just over 1%. Intuitively, the prevalence of vWd in women with menorrhagia is probably higher since platelet plug formation is necessary for menstrual hemostasis. Current management of menorrhagia in patients in the United States often begins with hormonal therapy. Estrogen and estrogen derivatives in oral contraceptives have been shown to increase von Willebrand factor (vWf) levels. Women with menorrhagia who have vWd or who are hemophilia A carriers have also been successfully treated with desmopressin acetate (DDAVP, Stimate® Nasal Spray). Tranexamic acid (Cyklokapron) is utilized extensively for menorrhagia in Australia and the United Kingdom. Standard hormonal therapy has not been compared with desmopressin or antifibrinolytics for menorrhagia. This study will compare treatment options for women with menorrhagia who have a detectable bleeding disorder. Investigators will document the effect on quality of life, menstrual flow, and coagulation parameters of treatment with oral contraceptive pills, desmopressin, or tranexamic acid.
- Conditions
- Menorrhagia, Blood Coagulation Disorders, Blood Platelet Disorders, Von Willebrand Disease, Hematologic Disease
- Being tested
- Tranexamic Acid, Desmopressin Acetate
- Keywords
- Menorrhagia, Von Willebrand's Disease, Platelet Disorder
- Medical subject headings
- Menorrhagia, Blood Coagulation Disorders, Blood Platelet Disorders, von Willebrand Diseases, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Desmopressin AcetateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of menstrual blood loss as measured by a Pictorial Self-Assessment Chart
Changes in quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2005 (estimated)
- Study startJan 2001
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- Nicole F Dowling, PhD, Study director, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111215
- Sponsor's protocol ID
- CDC-NCBDDD-2906
- Status last verified
- Jun 2006
- First submitted
- 18 May 2005
- Last updated
- 13 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Management of Women With Bleeding Disorders
- ClinicalTrials.gov ID
- NCT00111215
- Acronym / sponsor ID
- CDC-NCBDDD-2906
- Conditions
- Menorrhagia, Blood Coagulation Disorders, Blood Platelet Disorders, Von Willebrand Disease, Hematologic Disease
- Keywords
- Menorrhagia, Von Willebrand's Disease, Platelet Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Jan 2001
- Study completion
- Sep 2006
- First posted
- 19 May 2005 (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.
The purpose of the study is to determine whether oral contraceptives, desmopressin acetate, and/or tranexamic acid are effective in the treatment of women with menorrhagia who are diagnosed with a bleeding disorder.
Detailed description
Menorrhagia is a common clinical problem. Morbid events include dysmenorrhea, hospitalizations, red blood cell transfusions, and quality of life impairment in terms of daily activities, chronic pain, and time lost from work and or school. Up to 60% of women with uncontrolled menorrhagia undergo hysterectomy. Up to 20% of women with menorrhagia may have undiagnosed von Willebrand disease (vWd), or other bleeding disorders. Prevalence of vWd in the general population is estimated at just over 1%. Intuitively, the prevalence of vWd in women with menorrhagia is probably higher since platelet plug formation is necessary for menstrual hemostasis. Current management of menorrhagia in patients in the United States often begins with hormonal therapy. Estrogen and estrogen derivatives in oral contraceptives have been shown to increase von Willebrand factor (vWf) levels. Women with menorrhagia who have vWd or who are hemophilia A carriers have also been successfully treated with desmopressin acetate (DDAVP, Stimate® Nasal Spray). Tranexamic acid (Cyklokapron) is utilized extensively for menorrhagia in Australia and the United Kingdom. Standard hormonal therapy has not been compared with desmopressin or antifibrinolytics for menorrhagia. This study will compare treatment options for women with menorrhagia who have a detectable bleeding disorder. Investigators will document the effect on quality of life, menstrual flow, and coagulation parameters of treatment with oral contraceptive pills, desmopressin, or tranexamic acid.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Referred to study by gynecologist or internist/family practitioner with diagnosis of menorrhagia or referred by self through community advertising or networking
- Prospective pictorial chart scores of menses >100
- Negative pelvic exam and Pap smear within the past year. *Ultrasound if manual exam indicates abnormal uterine size; *Endometrial biopsy if >35 and non-cyclic bleeding; *Rule out acute pelvic diseases - gonorrhea, chlamydia
- Age 18-50
- Willing to go off oral contraceptives and selected drugs (including some nutritional supplements and drugs that affect coagulation such as aspirin and ibuprofen) for initial laboratory testing and throughout the cross-over drug portion of the study
Key exclusion criteria (13 listed)
- Patient is not proficient in English
- Patient is pregnant
- Patient on hormone replacement, Depo-Provera, or Norplant in last three months
- Patient has intrauterine device (IUD) present
- Patient is taking warfarin sodium (Coumadin) or other anti-coagulation therapy
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 |
|---|---|---|
| Tranexamic Acid | Drug | – |
| Desmopressin Acetate | Drug | – |
Primary outcome
Reduction of menstrual blood loss as measured by a Pictorial Self-Assessment Chart
Changes in quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2007.
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A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
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HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
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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.
Nicole F Dowling, PhD study director
Centers for Disease Control and Prevention
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid and Desmopressin Acetate in people with Menorrhagia and Blood Coagulation Disorders, run by Centers for Disease Control and Prevention at 6 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 13 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: finished, as of the sponsor's last update on 13 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of menstrual blood loss as measured by a Pictorial Self-Assessment Chart. The study lists 2 primary outcomes in all. 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 13 Mar 2007.