Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111215
Status:
COMPLETED
Last Update Posted:
2007-03-13
First Post:
2005-05-18
Brief Title:
Treatment and Management of Women With Bleeding Disorders
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Treatment and Management of Women With Bleeding Disorders
Status:
COMPLETED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine whether oral contraceptives desmopressin acetate andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None