Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation — Biomarkers  

Vaginal Infections Clinical Trial

Official title: Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation

Status Completed

Clinical Trial Summary

This study investigates the response of vaginal and cervical tissue after exposure to three vaginal products: hydroxyethyl cellulose (HEC) placebo, nonoxynol-9 (N9) and imiquimod (IMQ) cream.

Clinical Trial Description

Each woman in this study will be evaluated 5 separate times:

1. Baseline in the follicular phase of the menstrual cycle;

2. Baseline in the luteal phase of the menstrual cycle;

3. After a 3 day (4 dose) treatment with HEC placebo;

4. After a 3 day (4 dose) treatment of 4% N-9;

5. After a 2 day (2 dose) treatment of IMQ.

A subset of 5 women will have an additional baseline visit in the follicular phase.

The order of the N-9 and IMQ treatments is randomized. The study is cross over in design. The per sequence of treatments is as follows: Baseline in the follicular phase of the menstrual cycle, next is baseline in the luteal phase of the menstrual cycle, next is after a 3 day (4 dose) treatment with HEC placebo. At this point in the study, half of the participants are randomized to do the N-9 treatment and then the IMQ treatment. The remaining half of the participants do the IMQ treatment and then the N-9 treatment.

All participants are sampled at the 5 timepoints described above. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation
• Mucositis
• Vaginal Infections
• Vaginal Inflammation
• Vaginitis

• NCT number: NCT01593124
• Study type: Interventional
• Source: CONRAD
• Status: Completed
• Phase: Phase 2
• Start date: May 2012
• Completion date: April 2013