Amprevence Study

STUDY BASICS

Are you a healthy 18-45 year-old woman who has been diagnosed with gonorrhea or chlamydia in the past 4 months? If so, you may be able to participate in a research study to help find out if an investigational vaginal gel called Amphora™ can reduce the risk of chlamydia and gonorrhea infection. Compensation is provided.

STUDY PURPOSE

Chlamydia and gonorrhea are infections that are spread through sexual contact. At this time, using condoms is the only way to prevent the transmission of these infections. However, recent research suggests that lowering the pH of the vagina may help prevent these infections in women. The purpose of this study is to help researchers find out if using a new investigational vaginal gel called Amphora™ can reduce the risk of chlamydia and gonorrhea infection. Amphora vaginal gel is designed to maintain the normal, low pH of the vagina, even during and after sex. Researchers hope their findings will lead to new ways for women to protect themselves from sexually transmitted infections.

COULD THIS STUDY BE RIGHT FOR YOU?

• Women ages 18-45
• Diagnosed with gonorrhea and/or chlamydia in the past 4 months
• Had vaginal sexual intercourse with a male partner at least 3 times per month in the past month and expect to have regular sexual intercourse for the duration of the 6 month study
• Agree to use a woman-controlled method of birth control (oral contraceptives, vaginal ring, birth control implant, IUD, or tubal ligation). Condom-only use is NOT an acceptable form of birth control to use during this study.
• Not using contraceptive products that are directly applied to or inserted in the vagina (diaphragms, spermicides, or nonoxylnol-9-containing products). The contraceptive vaginal ring is allowed.
• Not currently pregnant or breastfeeding
• Have not had a total hysterectomy to remove the uterus and cervix

WHAT PARTICIPANTS CAN EXPECT

Participants will be randomly assigned (like the flip of a coin) to receive either the Amphora™ gel or a placebo gel. The placebo gel looks like the Amphora gel but has no active ingredient. Participants will use the gel each time they have sex and will return for follow-up visits once per month for 5 months. At each follow-up visit, participants will bring and return all used and unused study product, and will be given fresh supplies as needed. At the end of the study, participants will complete two questionnaires about their experiences. Participants will also be tested for chlamydia, gonorrhea, and pregnancy throughout the study.