Trials / Completed
CompletedNCT00111215
Treatment and Management of Women With Bleeding Disorders
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (planned)
- Sponsor
- Centers for Disease Control and Prevention · Federal
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Menorrhagia
- Blood Coagulation Disorders
- Blood Platelet Disorders
- Von Willebrand Disease
- Hematologic Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tranexamic Acid | |
| DRUG | Desmopressin Acetate |
Timeline
- Start date
- 2001-01-01
- Completion
- 2006-09-01
- First posted
- 2005-05-19
- Last updated
- 2007-03-13
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00111215. Inclusion in this directory is not an endorsement.