Trial Information

Summary: Effect of Repeated Applications of PRO 2000/5 Gel (P) on Inflammatory Mediators in Cervicovaginal Secretions in Women at Low Risk for HIV-1 Infection - 14 Day Trial

Microbicides are products intended for use in the vagina to protect against the transmission of sexually transmitted infections, including HIV. We are looking for healthy women who are willing to test a vaginal gel. The purpose of this research study is to see if using this gel vaginally for 14 days causes inflammation. Participants will complete a screening visit at the Mount Sinai Medical Center to see if they are eligible for participation. The screening visit will include a pelvic exam to test for sexually transmitted infections, a pap smear, urine testing for pregnancy and infection, and blood tests for HIV and syphilis. If you are enrolled in the study, you will apply the gel at home for two weeks and complete weekly visits at Mount Sinai for one month. Financial compensation will be provided. For more information, please call 212-241-9710 or 212-241-5890.
Compensation Provided

Patient Inclusion/Exclusion Criteria:

Women between 18 and 50 years old.
Normal menstrual history with regular cycles with a minimum of 21 days between menses.
No change in hormonal contraceptive use over last three months.
Low risk for HIV and sexually transmitted infections.
Agree to abstain from sexual intercourse and to not use vaginal products for 48 hours prior to enrollment and for the duration of the study.
Agree to undergo colposcopic assessment and biopsy (if indicated).

Pregnant, breastfeeding, or menopausal.
HIV, a sexually transmitted infection, or a urinary tract infection at screening.
Abnormal Pap smear at screening or signs of cervical dysplasia present.
History of intermenstrual bleeding in the 3 months prior to enrollment.
History of gynecological surgery or syphilis, genital herpes, chlamydia, gonorrhea, trichomonas, or genital warts in the last 3 months.
History of vaginal or urinary tract infection in the prior month.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.