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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00154089

Enrollment

Registered

2005-09-12

Start date

2004-11-30

Completion date

2006-12-31

Last updated

2016-02-23

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

Conditions

Cervical Intraepithelial Neoplasia

Keywords

cervical intraepithelial neoplasia, CIN, HPV

Brief summary

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.

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

DRUGEM-1421

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years of age or older * Negative pregnancy test * Biopsy confirmed CIN 1, 2, or 3

Exclusion criteria

* Pregnancy or breast feeding

Countries

United States

Outcome results

None listed

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