A Study of BufferGel in Women

Exclusion Criteria

• •Co-existing Condition:
• •Participants with the following conditions or symptoms are excluded:
• •A Grade 3 or higher liver, renal, or hematology abnormality.
• •Menopausal.
• •Breakthrough menstrual bleeding.
• •Any STD or symptoms, as seen on pelvic exam, consistent with an STD or other genital tract infection or trauma including vaginitis, cervicitis, edema, erythema, ecchymosis, petechial hemorrhage, vulvar or cervicovaginal lesions or abrasions, subepithelial hemorrhage, or signs of genital tract infection (other than asymptomatic bacterial vaginosis) from laboratory evaluations.
• •Concurrent Medication:
• •Excluded:
• •Any vaginal product other than BufferGel, including lubricants and feminine hygiene products.
• •Vaginal drying agents.
• •Douche.
• •Participation in any other microbicide or contraceptive study.
• •Treatment for any STD.
• •Participants with the following prior conditions are excluded:
• •IUD, abnormal PAP smear, pregnancy, abortion, or gynecologic surgery in the last 3 months.
• •Any of the following side effects related to Depo-provera use in the past 2 months:
• •headaches, dizziness, abdominal pain, fatigue, or nervousness.
• •Prior Medication:
• •Excluded:
• •A course of antibiotic therapy (other than treatment for malaria) in the last 14 days.
• •Any spermicide within the past month.
• •Initiation of Depo-provera for contraceptive purposes in the last 6 months.
• •Risk Behavior:
• •Excluded:
• •Use of intravenous drugs currently or within the past year.