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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Intraepithelial Neoplasia

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Trial Information

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


Inclusion Criteria:



- 18 years of age or older

- Negative pregnancy test

- Biopsy confirmed CIN 1, 2, or 3

Exclusion Criteria:

- Pregnancy or breast feeding

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

EM-1421 #201

NCT ID:

NCT00154089

Start Date:

September 2004

Completion Date:

July 2006

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • cervical intraepithelial neoplasia
  • CIN
  • HPV
  • Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

Name

Location

Planned Parenthood of DelawareWilmington, Delaware  19801
University of Maryland, Dept. of Family MedicineBaltimore, Maryland  21201