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Anti-Estrogen Therapy for Hereditary Hemorrhagic Telangiectasia A Double-Blind Placebo-Controlled Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00375622
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : September 13, 2006
Information provided by:
Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Hereditary Hemorrhagic Telangiectasia Drug: Tamoxifen Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : February 2005
Study Completion Date : June 2006

Primary Outcome Measures :
  1. Frequency of epistaxis.
  2. Duration of epistaxis.
  3. Hemoglobin level.

Secondary Outcome Measures :
  1. Quality of life.
  2. Nasal airway.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00375622

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Rabin Medical Center
Petah Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
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Study Chair: Eitan Yaniv, MD Rabin Medical Center, Clalit Health Services
Layout table for additonal information Identifier: NCT00375622    
Other Study ID Numbers: 3393
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: September 13, 2006
Last Verified: September 2006
Keywords provided by Rabin Medical Center:
Additional relevant MeSH terms:
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Telangiectasia, Hereditary Hemorrhagic
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents