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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00154089
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 23, 2016
University of Maryland, Baltimore County
Planned Parenthood Delaware (Wilmington, DE)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Drug: EM-1421 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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)

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
Other Names:
  • Terameprocol
  • M4N
  • Tetra-O-Methyl Nordihydroguaiaretic Acid

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy or breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00154089

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United States, Maryland
University of Maryland, Dept. of Family Medicine
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Erimos Pharmaceuticals
University of Maryland, Baltimore County
Planned Parenthood Delaware (Wilmington, DE)

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Responsible Party: Erimos Pharmaceuticals Identifier: NCT00154089     History of Changes
Other Study ID Numbers: EM-1421 #201
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: August 2006
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Erimos Pharmaceuticals:
cervical intraepithelial neoplasia

Additional relevant MeSH terms:
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Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Lipoxygenase Inhibitors
Enzyme Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents