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

Cervical Intraepithelial Neoplasia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154089
• Other study ID #: EM-1421 #201
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 8, 2005
• Last updated: February 20, 2016
• Start date: November 2004
• Est. completion date: December 2006

Study information

• Verified date: August 2006
• Source: Erimos Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Negative pregnancy test

• Biopsy confirmed CIN 1, 2, or 3

Exclusion Criteria:

• Pregnancy or breast feeding

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Maryland, Dept. of Family Medicine	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Erimos Pharmaceuticals	Planned Parenthood Delaware (Wilmington, DE), University of Maryland, Baltimore County

Country where clinical trial is conducted

United States,