Title
A Pilot Study of EM-1421 for the Treatment of Cervical Intraepithelial Neoplasia
A Pilot Translational Study of Tetra-O-Methyl Nordihydroguaiaretic Acid (EM-1421) for the Treatment of Cervical Intraepithelial Neoplasia Induced by Human Papilloma Virus
Phase
Phase 1/Phase 2Lead Sponsor
Erimos PharmaceuticalsStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Cervical Intraepithelial NeoplasiaIntervention/Treatment
tetra-o-methyl nordihydroguaiaretic acid ...Study Participants
8The 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.
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.
EM-1421 administered intravaginally every 3 weeks as 45 mg (1% w/w) EM-1421 or 90 mg (2% w/w) 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)
Inclusion Criteria: 18 years of age or older Negative pregnancy test Biopsy confirmed CIN 1, 2, or 3 Exclusion Criteria: Pregnancy or breast feeding
