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

Erimos Pharmaceuticals8 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Intraepithelial Neoplasia

Interventions

EM-1421DRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Maryland, Dept. of Family Medicine

Baltimore, Maryland, United States

Data from ClinicalTrials.gov

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