A Pilot Study of EM-1421 for the Treatment of Cervical Intraepithelial Neoplasia
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2004 |
| End Date: | December 2006 |
A Pilot Translational Study of Tetra-O-Methyl Nordihydroguaiaretic Acid (EM-1421) for the Treatment of Cervical Intraepithelial Neoplasia Induced by Human Papilloma Virus
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.
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.
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.
Inclusion Criteria:
- 18 years of age or older
- Negative pregnancy test
- Biopsy confirmed CIN 1, 2, or 3
Exclusion Criteria:
- Pregnancy or breast feeding
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