Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 is a Phase 2 study that has completed, run by United States Naval Medical Center, San Diego. The registered enrollment target is 22 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Interventions

  • DRUG Imiquimod
  • PROCEDURE Loop Electrosurgical Excision Procedure

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2015-02
Est. Completion 2017-05-09
Phase Phase 2

What the Registry Record Tells You About NCT02130323

The ClinicalTrials.gov registry entry for NCT02130323 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Naval Medical Center, San Diego, which has 41 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Imiquimod is the first listed.

NCT02130323 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.