Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375622
Status:
COMPLETED
Last Update Posted:
2006-09-13
First Post:
2006-09-12
Brief Title:
Anti-Estrogen Therapy for Hereditary Hemorrhagic Telangiectasia A Double-Blind Placebo-Controlled Clinical Trial
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hereditary hemorrhagic telangiectasia HHT is associated with recurrent epistaxis in 90 of cases Good response to hormone treatment has been documented although its use remains controversial A double-blind placebo-controlled trial with estrogen treatment did not show any benefit over placebo The aim of this study is to examine the efficacy of an antiestrogenic agent TAMOXIFEN in the treatment of HHT-associated epistaxis The study will include up to 60 patients over 18 years old
Detailed Description:
Patients with HHT-related epistaxis who will attend our center will randomly be assigned to 6 months of treatment with either Tab tamoxifen 20 mg once daily or placebo The group will included both men and women over the age of 18 years
A detailed medical history will be taken at presentation All patients will be examined by an otolaryngologist before and during the trial to assess the nasal condition and telangiectases and blood clots in the airway nasal and oral cavity and body skin Blood will be collected for blood count and measurement of clotting time and liver function at onset of the trial and once monthly during treatment Patients will be requested to complete a daily chart describing the course of their epistaxis and female patients will be referred for gynecologic follow-up including ultrasound Evaluations will be conducted once a month throughout the treatment period
The study was approved by the Ethics Committee of Rabin Medical Center All patients will sign a consent form
A detailed medical history will be taken at presentation All patients will be examined by an otolaryngologist before and during the trial to assess the nasal condition and telangiectases and blood clots in the airway nasal and oral cavity and body skin Blood will be collected for blood count and measurement of clotting time and liver function at onset of the trial and once monthly during treatment Patients will be requested to complete a daily chart describing the course of their epistaxis and female patients will be referred for gynecologic follow-up including ultrasound Evaluations will be conducted once a month throughout the treatment period
The study was approved by the Ethics Committee of Rabin Medical Center All patients will sign a consent form
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