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| Sponsored by: |
Rabin Medical Center |
|---|---|
| Information provided by: | Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT00375622 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hereditary Hemorrhagic Telangiectasia |
Drug: Tamoxifen |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study |
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | June 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | 3393 |
| Study First Received: | September 12, 2006 |
| Last Updated: | September 12, 2006 |
| ClinicalTrials.gov Identifier: | NCT00375622 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
|
HHT Epistaxis Tamoxifen Hemoglobin |
|
Cardiovascular Abnormalities Hereditary hemorrhagic telangiectasia Epistaxis Telangiectasia, Hereditary Hemorrhagic Hematologic Diseases Blood Coagulation Disorders Vascular Diseases |
Hemostatic Disorders Tamoxifen Hemorrhagic Disorders Telangiectasis Vascular Malformations Congenital Abnormalities |
|
Estrogen Receptor Modulators Estrogen Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Therapeutic Uses |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Cardiovascular Diseases Selective Estrogen Receptor Modulators Pharmacologic Actions |
