Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation
Brief description: 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: Baseline in the follicular phase of the menstrual cycle; Baseline in the luteal phase of the menstrual cycle; After a 3 day (4 dose) treatment with HEC placebo; After a 3 day (4 dose) treatment of 4% N-9; 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.
Detailed description: Each woman in this study will be evaluated 5 separate times: Baseline in the follicular phase of the menstrual cycle; Baseline in the luteal phase of the menstrual cycle; After a 3 day (4 dose) treatment with HEC placebo; After a 3 day (4 dose) treatment of 4% N-9; 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.