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

Phase 1

Completed

• Conditions: Cervical Intraepithelial Neoplasia
• Interventions: Drug: EM-1421

• Registration Number: NCT00154089
• Lead Sponsor: Erimos Pharmaceuticals

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 Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2006-04
• Status Verified: 2006-08
• Study Completion: 2006-12
• Last Update Submitted: 2016-02-20
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

• 18 years of age or older
• Negative pregnancy test
• Biopsy confirmed CIN 1, 2, or 3

Exclusion Criteria

• Pregnancy or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EM-1421	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)

Trial Locations

Locations (1)

University of Maryland, Dept. of Family Medicine; 🇺🇸 Baltimore, Maryland, United States