Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
Phase 3 Randomized Controlled Trial of Non-inferiority of Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix
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.
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.
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
We found this trial at
1
site
34800 Bob Wilson Dr,
San Diego, California 92134
San Diego, California 92134
(619) 532-6400
Principal Investigator: Addie N Alkhas, MD
Phone: 619-532-9927
Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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