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

This study has been completed.
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00375622
First received: September 12, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375622

Locations
Israel
Rabin Medical Center
Petah Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Investigators
Study Chair: Eitan Yaniv, MD Rabin Medical Center, Clalit Health Services
  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 July 28, 2014