Baltimore, Maryland 21201

  • Cervical Intraepithelial Neoplasia

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 18 years of age or older - Negative pregnancy test - Biopsy confirmed CIN 1, 2, or 3 Exclusion Criteria: - Pregnancy or breast feeding


NCT ID:

NCT00154089


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

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