Phase 2B Double-blind Placebo-controlled Efficacy Trial of EVO100 (Previously Known as Amphora ® Gel) for the Prevention of Acquisition of Urogenital Chlamydia Trachomatis Infection
Phase 2B double-blind placebo-controlled efficacy trial of EVO100 (previously known as Amphora ® Gel) for the prevention of acquisition of urogenital Chlamydia trachomatis infection
• Healthy female subjects between 18 and 45 years, inclusive
• Ability to understand the consent process and procedures
• Subjects agree to be available for all study visits
• Written informed consent in accordance with institutional guidelines
• Negative pregnancy test
• Negative CT and GC NAAT tests OR positive CT or GC NAAT and receives standard of care (SOC) treatment
• Agree to use a woman-controlled method of contraception, such as oral contraceptives, vaginal ring, birth control implants, IUDs, or tubal ligation (with the exception of spermicides, diaphragms, or any vaginally applied or inserted products containing nonoxynol-9). Condom use only is not an acceptable form of contraception for this study.
• Able and willing to comply with all study procedures
• Documented (as part of a retrievable medical record) CT or GC infection within 16 weeks prior to enrollment
⁃ Reports vaginal sexual intercourse with a male partner at least 3 times per month in the previous month and anticipates vaginal sexual intercourse regularly for the duration of the study
⁃ Agree to abstain from douching or any form of vaginal suppository use (other than study product) during course of study