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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00375622
Enrollment
60
Registered
2006-09-13
Start date
2005-02-28
Completion date
2006-06-30
Last updated
2006-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Hemorrhagic Telangiectasia

Keywords

HHT, Epistaxis, Tamoxifen, Hemoglobin

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.

Interventions

DRUGTamoxifen

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Frequency of epistaxis.
Duration of epistaxis.
Hemoglobin level.

Secondary

MeasureTime frame
Quality of life.
Nasal airway.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026