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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Cervical Intraepithelial Neoplasia
 Drug: EM-1421
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Erimos Pharmaceuticals:

Estimated Enrollment: 8
Study Start Date: September 2004
Estimated Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy or breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00154089

Locations
United States, Delaware
Planned Parenthood of Delaware
Wilmington, Delaware, United States, 19801
United States, Maryland
University of Maryland, Dept. of Family Medicine
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Erimos Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00154089     History of Changes
Other Study ID Numbers: EM-1421 #201
Study First Received: September 8, 2005
Last Updated: August 10, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Erimos Pharmaceuticals:
cervical intraepithelial neoplasia
CIN
HPV

Additional relevant MeSH terms:
Neoplasms
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Nordihydroguaiaretic Acid
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antioxidants
 Protective Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013