Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Vaginal InflammationVaginal Infections
Interventions
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.

Trial Locations (1)

23507

Eastern Virginia Medical School CONRAD Clinical Research Center, Norfolk

All Listed Sponsors
lead

CONRAD

OTHER

NCT01593124 - Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation | Biotech Hunter | Biotech Hunter