NCT01593124

Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: CONRAD · Academic / Other
• Sex: Female
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Vaginal Inflammation
• Vaginal Infections

Interventions

Type	Name	Description
DRUG	Imiquimod	Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.
OTHER	Placebo	Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.
DRUG	Nonoxynol-9	Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-05-07
• Last updated: 2015-03-31

Locations

1 site across 1 country: United States