A Pilot Study of EM-1421 for the Treatment of Cervical Intraepithelial Neoplasia

Overview

The primary objective of this study is to determine pilot safety and efficacy data for a topical formulation of EM-1421 applied to the cervix of patients with CIN 1, 2, or 3.

Full Title of Study: “A Pilot Translational Study of Tetra-O-Methyl Nordihydroguaiaretic Acid (EM-1421) for the Treatment of Cervical Intraepithelial Neoplasia Induced by Human Papilloma Virus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2006

Detailed Description

This was an open-label, pilot Phase I/II dose evaluation and pharmacokinetic evaluation study to compare the safety and efficacy of terameprocol (45mg or 90mg/application)administered once per week for 3 weeks to the cervix uteri in patients with biopsy-proven CIN. Patients who met eligibility criteria visited the clinic weekly for terameprocol application. Patients kept a daily diary card record of genitourinary symptoms.

Interventions

  • Drug: EM-1421
    • EM-1421 administered intravaginally every 3 weeks as 45 mg (1% w/w) EM-1421 or 90 mg (2% w/w) EM-1421

Arms, Groups and Cohorts

  • Experimental: EM-1421
    • Administration of EM-1421 intravaginally once per week for 3 weeks Dose level of 45 mg/application (1% w/w) or 90 mg/application (2% w/w)

Participating in This Clinical Trial

Inclusion Criteria

  • 18 years of age or older – Negative pregnancy test – Biopsy confirmed CIN 1, 2, or 3 Exclusion Criteria:
  • Pregnancy or breast feeding
  • Gender Eligibility: Female

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Erimos Pharmaceuticals
    • Collaborator
      • University of Maryland, Baltimore County
    • Provider of Information About this Clinical Study
      • Sponsor

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