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

Erimos Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Drug: EM-1421

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00154089

EM-1421 #201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnancy or breast feeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

EM-1421

Experimental group

Description:

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)

Treatment:

Drug: EM-1421