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

This study has been completed.
Sponsor:
Information provided by:
Erimos Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00154089
First received: September 8, 2005
Last updated: August 10, 2006
Last verified: August 2006

September 8, 2005
August 10, 2006
September 2004
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Complete list of historical versions of study NCT00154089 on ClinicalTrials.gov Archive Site
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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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervical Intraepithelial Neoplasia
Drug: EM-1421
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
July 2006
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Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy or breast feeding
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00154089
EM-1421 #201
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Erimos Pharmaceuticals
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Erimos Pharmaceuticals
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP