Overview

This trial is active, not recruiting.

Condition cervical intraepithelial neoplasia
Treatments imiquimod, loop electrosurgical excision procedure
Phase phase 2/phase 3
Sponsor United States Naval Medical Center, San Diego
Start date February 2015
End date December 2016
Trial size 22 participants
Trial identifier NCT02130323, NMCSD.2014.0040

Summary

OBJECTIVE: The standard of care for high grade cervical intraepithelial neoplasia grade 2 to 3 (CIN 2-3) has been the excision of the cervical transformation zone by way of a loop electrosurgical excision procedure (LEEP) or cold knife conization (CKC). However, it has been recognized that these procedures can increase the risks for pre-term labor in women who still desire to conceive. Recent studies have shown that medical treatment with Imiquimod, a topical immune response modulator, has significant effects on histological regression of CIN 2-3 when compared with placebo. The investigators propose that treatment with Imiquimod may be preferable offering similar outcomes on histological regression when compared with excision or ablation while potentially avoiding or reducing the number of surgical procedure that places them at risk for future pregnancies.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Excision of the cervical transformation zone by way of the loop electrosurgical excision procedure (LEEP) or cold knife conization (CKC).
loop electrosurgical excision procedure LEEP
Patients with CIN 2-3 will be randomized to receive intervention, CKC or LEEP versus medical therapy with Imiquimod.
(Experimental)
Imiquimod 12.5mg intravaginally once weekly for 16 weeks
imiquimod Aldara
12.5mg (5%) once a week vaginally for 16 weeks

Primary Outcomes

Measure
Human Papillomavirus(HPV) Clearance
time frame: 6 months from treatment initiation

Secondary Outcomes

Measure
Evidence of local or systemic side effects of Imiquimod cream
time frame: Every 4 weeks after initiation of Imiquimod Arm for 16 weeks
Evidence of local or systemic side effects of Imiquimod cream
time frame: Daily after initiation of Imiquimod treatment Arm, up to 6 months after study initiation
Number of Participants with Serious and Non-Serious Adverse Events
time frame: Up to 6 months after study initiation

Eligibility Criteria

Female participants at least 21 years old.

Inclusion Criteria: - Healthy women older than age 21, military or civilian - Negative pregnancy test results - Confirmed CIN 2-3 on cervical biopsy with a negative endocervical curettage (ECC) and satisfactory colposcopy visualizing the complete transformation zone of the cervix. - The patient will be available and in the San Diego area for 6 months after enrollment to complete the clinic visits and follow up. Exclusion Criteria: - Positive CIN 2-3 on ECC - Presence of cancer - Pregnancy or lactation - Immuno-compromised (systemic lupus erythematosus, kidney transplant) - Hepatitis - Hypersensitivity to Imiquimod - Ulcerative colitis - Crohn's disease - Human Immunodeficiency virus

Additional Information

Official title Phase 3 Randomized Controlled Trial of Non-inferiority of Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix
Principal investigator Addie N Alkhas, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by United States Naval Medical Center, San Diego.