Aromatase Inhibitors for Treatment of Uterine Leiomyomas

NCT00945360 | Withdrawn Phase 1 DMC

• 1 other identifier: OGY.AN.08
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Fibroids are benign tumors that might results in bleeding. Surgery is their definitive treatment. Some medical therapies have been tried for women who wish to preserve their uterus. Recent reports have demonstrated a role for a new category of drugs called aromatase inhibitor (such as Femara) in the treatment of fibroids. This study is conducted to assess the effect of Femara (letrozole) on the size of fibroids in women around menopause.

Conditions

Symptomatic or Large Uterine Fibroids

Keywords

Leiomyoma; perimenopause; aromatase inhibitor

Outcome Measures

Primary Outcomes (1)

• The primary end point of this study will be the baseline to end point percent difference in leiomyoma volume at 2 months and 6 months following treatment with Letrozole.

  2 months and 6 months following treatment

Secondary Outcomes (4)

• Improvement in symptoms

  2 and 6 months following treatment

• Need for a surgical intervention

  2 and 6 months following treatment

• Improvement in the hemoglobin levels

  2 and 6 months following treatment

• Development of side effects: hot flushes, nausea,vomiting, headache, thrombophlebitis

  2 and 6 months following treatment

Study Arms (1)

aromatase inhibitors: Letrozole

EXPERIMENTAL

All consenting patients will be started on Letrozole at a dose of 2.5 mg/day for 8 weeks.

Drug: Letrozole (aromatase inhibitor)

Interventions

Letrozole (aromatase inhibitor) DRUG

Letrozole at a dose of 2.5 mg/day for 8 weeks.

Also known as: Letrozole

aromatase inhibitors: Letrozole

Eligibility Criteria

• Age: 50 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Perimenopausal women (≥ 50 years) with symptomatic uterine leiomyomas (menometrorrhagia, pressure symptoms, urinary retention, pelvic pain) or those with large leiomyomas ≥ 7 cms

You may not qualify if:

• Women \<50 years of age
• Postmenopausal women
• Women with impaired renal function
• Oral treatment with any type of estrogen or progesterone more recently than 1 month
• History of venous thromboembolism
• Any contraindication for Magnetic Resonance Imaging (MRI)

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut

Beirut, Lebanon

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

Letrozole; Aromatase Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Study Officials

• Anwar H Nassar, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 24, 2009
• Study Start: March 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 13, 2012

Record last verified: 2009-07

Locations

LE (1)