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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 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.
Sponsor: Erimos Pharmaceuticals

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Erimos Pharmaceuticals

Dates:
Date Received: September 8, 2005
Date Started: November 2004
Date Completion:
Last Updated: February 20, 2016
Last Verified: August 2006