A Pilot Study of EM-1421 for the Treatment of Cervical Intraepithelial Neoplasia
NCT00154089 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2016-02-23
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.
Conditions
- Cervical Intraepithelial Neoplasia
Interventions
- 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
Sponsors & Collaborators
-
University of Maryland, Baltimore County
collaborator OTHER -
Planned Parenthood Delaware (Wilmington, DE)
collaborator UNKNOWN -
Erimos Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-11-30
- Primary Completion
- 2006-04-30
- Completion
- 2006-12-31
Countries
- United States
Study Locations
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