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

Phase 2

Completed

• Conditions: Hereditary Hemorrhagic Telangiectasia

• Registration Number: NCT00375622
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2005-02
• Study Completion: 2006-06
• Status Verified: 2006-09
• Study First Submitted: 2006-09-12
• Study First Submitted QC: 2006-09-12
• Last Update Submitted: 2006-09-12
• Study First Posted: 2006-09-13
• Last Update Posted: 2006-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of epistaxis.
Duration of epistaxis.
Hemoglobin level.

Secondary Outcome Measures

Name	Time	Method
Quality of life.
Nasal airway.

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel