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

Primary Purpose

Cervical Intraepithelial Neoplasia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

EM-1421

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia focused on measuring cervical intraepithelial neoplasia, CIN, HPV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 18 years of age or older Negative pregnancy test Biopsy confirmed CIN 1, 2, or 3 Exclusion Criteria: Pregnancy or breast feeding

Sites / Locations

University of Maryland, Dept. of Family Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EM-1421

Arm 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)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00154089

First Posted

September 8, 2005

Last Updated

February 20, 2016

Sponsor

Erimos Pharmaceuticals

Collaborators

University of Maryland, Baltimore County, Planned Parenthood Delaware (Wilmington, DE)

1. Study Identification

Unique Protocol Identification Number

NCT00154089

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2006

Overall Recruitment Status

Completed

Study Start Date

November 2004 (undefined)

Primary Completion Date

April 2006 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Erimos Pharmaceuticals

Collaborators

University of Maryland, Baltimore County, Planned Parenthood Delaware (Wilmington, DE)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Intraepithelial Neoplasia

Keywords

cervical intraepithelial neoplasia, CIN, HPV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EM-1421

Arm Type

Experimental

Arm 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)

Intervention Type

Drug

Intervention Name(s)

EM-1421

Other Intervention Name(s)

Terameprocol, M4N, Tetra-O-Methyl Nordihydroguaiaretic Acid

Intervention Description

EM-1421 administered intravaginally every 3 weeks as 45 mg (1% w/w) EM-1421 or 90 mg (2% w/w) EM-1421

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

University of Maryland, Dept. of Family Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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