Anti-Estrogen Therapy for Hereditary Hemorrhagic Telangiectasia A Double-Blind Placebo-Controlled Clinical Trial
|ClinicalTrials.gov Identifier: NCT00375622|
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : September 13, 2006
|Condition or disease||Intervention/treatment||Phase|
|Hereditary Hemorrhagic Telangiectasia||Drug: Tamoxifen||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Study Start Date :||February 2005|
|Estimated Study Completion Date :||June 2006|
U.S. FDA Resources
- Frequency of epistaxis.
- Duration of epistaxis.
- Hemoglobin level.
- Quality of life.
- Nasal airway.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375622
|Rabin Medical Center|
|Petah Tikva, Israel, 49100|
|Study Chair:||Eitan Yaniv, MD||Rabin Medical Center, Clalit Health Services|