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

NCT ID: NCT00154089

Last Updated: 2016-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Cervical Intraepithelial Neoplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

EM-1421

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Terameprocol M4N Tetra-O-Methyl Nordihydroguaiaretic Acid

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy or breast feeding
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore County

OTHER

Sponsor Role collaborator

Planned Parenthood Delaware (Wilmington, DE)

UNKNOWN

Sponsor Role collaborator

Erimos Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Maryland, Dept. of Family Medicine

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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EM-1421 #201

Identifier Type: -

Identifier Source: org_study_id

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