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

This study has been completed.
Sponsor:
Collaborators:
University of Maryland, Baltimore County
Planned Parenthood Delaware (Wilmington, DE)
Information provided by (Responsible Party):
Erimos Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00154089
First received: September 8, 2005
Last updated: February 20, 2016
Last verified: August 2006
  Purpose
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 Intervention Phase
Cervical Intraepithelial Neoplasia
Drug: EM-1421
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Erimos Pharmaceuticals:

Enrollment: 8
Study Start Date: November 2004
Study Completion Date: December 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154089

Locations
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)
  More Information

Responsible Party: Erimos Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00154089     History of Changes
Other Study ID Numbers: EM-1421 #201 
Study First Received: September 8, 2005
Last Updated: February 20, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Erimos Pharmaceuticals:
cervical intraepithelial neoplasia
CIN
HPV

Additional relevant MeSH terms:
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Masoprocol
Antioxidants
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 30, 2016