Status:
COMPLETED
A Pilot Study of EM-1421 for the Treatment of Cervical Intraepithelial Neoplasia
Lead Sponsor:
Erimos Pharmaceuticals
Collaborating Sponsors:
University of Maryland, Baltimore County
Planned Parenthood Delaware (Wilmington, DE)
Conditions:
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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 fo...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Negative pregnancy test
- Biopsy confirmed CIN 1, 2, or 3
Exclusion
- Pregnancy or breast feeding
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00154089
Start Date
November 1 2004
End Date
December 1 2006
Last Update
February 23 2016
Active Locations (1)
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1
University of Maryland, Dept. of Family Medicine
Baltimore, Maryland, United States, 21201