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

This study has been completed.
Sponsor:
Collaborators:
University of Maryland, Baltimore County
Planned Parenthood Delaware (Wilmington, DE)
Information provided by (Responsible Party):
Erimos Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00154089
First received: September 8, 2005
Last updated: February 20, 2016
Last verified: August 2006

September 8, 2005
February 20, 2016
November 2004
April 2006   (final data collection date for primary outcome measure)
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Not Provided
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.
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.
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervical Intraepithelial Neoplasia
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
Other Names:
  • Terameprocol
  • M4N
  • Tetra-O-Methyl Nordihydroguaiaretic Acid
Experimental: EM-1421

Administration of EM-1421 intravaginally once per week for 3 weeks

Dose level of 45 mg/application (1% w/w) or 90 mg/application (2% w/w)

Intervention: Drug: EM-1421
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
December 2006
April 2006   (final data collection date for primary outcome measure)

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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00154089
EM-1421 #201
No
No
Not Provided
Erimos Pharmaceuticals
Erimos Pharmaceuticals
  • University of Maryland, Baltimore County
  • Planned Parenthood Delaware (Wilmington, DE)
Not Provided
Erimos Pharmaceuticals
August 2006

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