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NCT02130323 · ClinicalTrials.gov registry record · Phase 2
Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix
A Phase 2 study, sponsored by United States Naval Medical Center, San Diego.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT02130323: Completed Phase 2 study, sponsored by United States Naval Medical Center, San Diego.
NCT02130323 is a Phase 2 study that has completed, run by United States Naval Medical Center, San Diego. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02130323, a Phase 2 study, has completed, sponsored by United States Naval Medical Center, San Diego.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study 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.
Primary Outcome
HPV clearance will be determined by pathology and HPV testing, followed by colposcopy. Descriptive statistics will include numbers and rates of occurrence with confidence intervals of regression, pre and post-treatment HPV including Human Papillomavirus type 16 (HPV16) and HPV 18/45 typing, and adverse effects. A non-inferiority type design is used in which the difference between treatments is defined as medical treatment being preferable if the regression rate is not more than 10% below that o
Interventions
- DRUG Imiquimod
- PROCEDURE Loop Electrosurgical Excision Procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2015-02 |
| Est. Completion | 2017-05-09 |
| Phase | Phase 2 |
What the finished NCT02130323 record still lists
NCT02130323 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Imiquimod is the first listed.
NCT02130323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02130323 about?
NCT02130323 is a clinical study titled "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 pro...
What is the current status of trial NCT02130323?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2015-02. Estimated completion is 2017-05-09.
What interventions are being tested in trial NCT02130323?
The interventions under investigation include: Imiquimod (DRUG), Loop Electrosurgical Excision Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT02130323?
This trial is sponsored by United States Naval Medical Center, San Diego, which has 41 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02130323's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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