Spots Global Cancer Trial Database for A Pilot Study of EM-1421 for the Treatment of Cervical Intraepithelial Neoplasia
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Trial Identification
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 ID: NCT00154089
Conditions
Interventions
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Maryland, Dept. of Family Medicine, Baltimore, Maryland, United States
Contact Details
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