NCT00375622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
Last Updated

September 13, 2006

Status Verified

September 1, 2006

First QC Date

September 12, 2006

Last Update Submit

September 12, 2006

Conditions

Hereditary Hemorrhagic Telangiectasia

Keywords

HHTEpistaxisTamoxifenHemoglobin

Outcome Measures

Primary Outcomes (3)

  • Frequency of epistaxis.

  • Duration of epistaxis.

  • Hemoglobin level.

Secondary Outcomes (2)

  • Quality of life.

  • Nasal airway.

Interventions

TamoxifenDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from HHT with severe epistaxis
  • Over 18 years old

You may not qualify if:

  • Under 18 years old
  • Pregnancy
  • Treatment with anticoagulance
  • Treatment with hormones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Telangiectasia, Hereditary HemorrhagicEpistaxis

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesTelangiectasisHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Eitan Yaniv, MD

    Rabin Medical Center, Clalit Health Services

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2006

First Posted

September 13, 2006

Study Start

February 1, 2005

Study Completion

June 1, 2006

Last Updated

September 13, 2006

Record last verified: 2006-09

Locations

IL(1)