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Treatment and Management of Women With Bleeding Disorders

Primary Purpose

Menorrhagia, Blood Coagulation Disorders, Blood Platelet Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Desmopressin Acetate
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Menorrhagia focused on measuring Menorrhagia, Von Willebrand's Disease, Platelet Disorder

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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) 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

Sites / Locations

  • Emory University School of Medicine
  • Michigan State University
  • The Mayo Clinic
  • UMDNJ Robert Wood Johnson Medical School
  • Mary M. Gooley Hemophilia Center
  • Duke University Medical Center

Outcomes

Primary Outcome Measures

Reduction of menstrual blood loss as measured by a Pictorial Self-Assessment Chart
Changes in quality of life

Secondary Outcome Measures

Full Information

First Posted
May 18, 2005
Last Updated
March 12, 2007
Sponsor
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00111215
Brief Title
Treatment and Management of Women With Bleeding Disorders
Official Title
Treatment and Management of Women With Bleeding Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia, Blood Coagulation Disorders, Blood Platelet Disorders, Von Willebrand Disease, Hematologic Disease
Keywords
Menorrhagia, Von Willebrand's Disease, Platelet Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Type
Drug
Intervention Name(s)
Desmopressin Acetate
Primary Outcome Measure Information:
Title
Reduction of menstrual blood loss as measured by a Pictorial Self-Assessment Chart
Title
Changes in quality of life

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole F Dowling, PhD
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Study Director
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48864
Country
United States
Facility Name
The Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
UMDNJ Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Mary M. Gooley Hemophilia Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Treatment and Management of Women With Bleeding Disorders

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