NCT00154089

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

February 23, 2016

Status Verified

August 1, 2006

Enrollment Period

1.4 years

First QC Date

September 8, 2005

Last Update Submit

February 20, 2016

Conditions

Cervical Intraepithelial Neoplasia

Keywords

cervical intraepithelial neoplasiaCINHPV

Study Arms (1)

EM-1421

EXPERIMENTAL

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)

Drug: EM-1421

Interventions

EM-1421DRUG

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

Also known as: Terameprocol, M4N, Tetra-O-Methyl Nordihydroguaiaretic Acid
EM-1421

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, Dept. of Family Medicine

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

terameprocol

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

November 1, 2004

Primary Completion

April 1, 2006

Study Completion

December 1, 2006

Last Updated

February 23, 2016

Record last verified: 2006-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)