NCT00264732

A Study of Amolimogene (ZYC101a) in Patients With High Grade Cervical Intraepithelial Lesions of the Uterine Cervix

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Amolimogene (ZYC101a) in the Treatment of High-Grade Cervical Intraepithelial Lesions (CIN 2/3) of the Uterine Cervix

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: Female
• Age: 13 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of amolimogene, in the treatment of patients with high-grade cervical intraepithelial lesions of the uterine cervix.

Detailed description

This is a double-blind study, so neither the patient not the doctor will know which treatment has been assigned.

Conditions

• Uterine Cervical Dysplasia

Interventions

Type	Name	Description
DRUG	Amolimogene	1-dose amolimogene Group: Two intramuscular (IM) injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM placebo injections (approximately 1 mL 0.9% sterile saline) at Weeks 3 and 6 in alternating quadriceps.
DRUG	Amolimogene	3-dose amolimogene Group: Two IM injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM injections of 100 micrograms ZYC101a at Weeks 3 and 6 in alternating quadriceps.
OTHER	Placebo	Placebo Group: Two IM placebo injections at Treatment Initiation (1 injection in each quadriceps). Single placebo injections at Weeks 3 and 6 in alternating quadriceps. Each placebo injection consists of approximately 1 mL 0.9% sterile saline.

Timeline

• Start date: 2005-07-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2005-12-13
• Last updated: 2013-05-29

Locations

26 sites across 1 country: United States