Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix

Completed · Phase 2/Phase 3

Conditions studied: Cervical Intraepithelial Neoplasia

In brief

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.

Key facts

Study ID

NCT02130323

Run by

United States Naval Medical Center, San Diego

People needed

22

Starts

2015-02-01

Expected to finish

2017-05-09

Last updated by the study team

2017-06-27

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Naval Medical Center San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.