Brief Title
A Pilot Study of EM-1421 for the Treatment of Cervical Intraepithelial Neoplasia
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 Description
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Condition
Cervical Intraepithelial Neoplasia
Intervention
EM-1421
Study Arms / Comparison Groups
EM-1421
Description: 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)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
8
Start Date
November 2004
Completion Date
December 2006
Primary Completion Date
April 2006
Eligibility 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00154089
Organization ID
EM-1421 #201
Responsible Party
Sponsor
Study Sponsor
Erimos Pharmaceuticals
Collaborators
University of Maryland, Baltimore County
Study Sponsor
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Verification Date
August 2006