Anti-Estrogen Therapy for Hereditary Hemorrhagic Telangiectasia A Double-Blind Placebo-Controlled Clinical Trial
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
- Frequency of epistaxis.
- Duration of epistaxis.
- Hemoglobin level.
- Quality of life.
- Nasal airway.
| 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:
- Patients suffering from HHT with severe epistaxis
- Over 18 years old
Exclusion Criteria:
- Under 18 years old
- Pregnancy
- Treatment with anticoagulance
- Treatment with hormones
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00375622 History of Changes |
| Other Study ID Numbers: | 3393 |
| Study First Received: | September 12, 2006 |
| Last Updated: | September 12, 2006 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Rabin Medical Center:
|
HHT Epistaxis Tamoxifen Hemoglobin |
Additional relevant MeSH terms:
|
Telangiectasia, Hereditary Hemorrhagic Telangiectasis Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders Hematologic Diseases Vascular Malformations Cardiovascular Abnormalities Congenital Abnormalities Tamoxifen |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013