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

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.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Maryland, Dept. of Family Medicine

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Pregnancy or breast feeding

Treatment and study plan

EM-1421

Drug

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

Other names: Terameprocol, M4N, Tetra-O-Methyl Nordihydroguaiaretic Acid

Sponsors and collaborators

Lead sponsor

Erimos Pharmaceuticals

Industry

Collaborators

Planned Parenthood Delaware (Wilmington, DE)
University of Maryland, Baltimore County

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Sep 12, 2005
Registry last updated: Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed