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

E

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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