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

This study has been completed.
Information provided by:
Rabin Medical Center Identifier:
First received: September 12, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
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

Resource links provided by NLM:

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Frequency of epistaxis.
  • Duration of epistaxis.
  • Hemoglobin level.

Secondary Outcome Measures:
  • Quality of life.
  • Nasal airway.

Estimated Enrollment: 60
Study Start Date: February 2005
Estimated Study Completion Date: June 2006
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.


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
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Please refer to this study by its identifier: NCT00375622

Rabin Medical Center
Petah Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Study Chair: Eitan Yaniv, MD Rabin Medical Center, Clalit Health Services
  More Information 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:

Additional relevant MeSH terms:
Telangiectasia, Hereditary Hemorrhagic
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Vascular Diseases
Vascular Malformations
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators processed this record on May 26, 2016