Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
This study will evaluate whether EVO100 vaginal gel prevents the sexual transmission of CT
 and GC infection
In this phase 3 double blind placebo controlled, efficacy study, women who have had a
 urogenital chlamydia or gonorrhea infection at any time over the 16 weeks preceding the
 enrollment Visit with one or more risk factors, or found to be positive for either infection
 at Screening Visit with one or more risk factors will be enrolled. After a screening period
 of up to 35 days, women will be randomized to receive either EVO100 vaginal gel or placebo.
 Each woman will participate in the study until she has completed 16 weeks of study medication
 or observation or tests positive for CT or GC infection.
Subject Recruitment: EVOGUARDStudy.com/ct

 Inclusion Criteria:

 -  Subjects must meet both of the following criteria:

 1. Urogenital CT and/or GC infection (documented in a retrievable medical record)
 within the 16 weeks prior to enrollment and one or more of the additional risk
 factors included below:

 -  18 to 24 years of age at the screening visit

 -  New sex partner within the past 12 weeks (84 days)

 -  More than one current sex partner

 -  Knowledge that current sex partner has multiple partners

 -  Partner with known sexually transmitted infection (STI)

 -  Inconsistent condom use among persons who are not in a mutually monogamous
 relationship

 2. After three unsuccessful documented attempts to obtain medical records, the
 subject has a self-reported history of infection less than 17 weeks prior to
 enrollment AND two or more of the following additional risk factors:

 -  18 to 24 years of age at the screening visit

 -  New sex partner within the past 12 weeks (84 days)

 -  More than one current sex partner

 -  Knowledge that current sex partner has multiple partners

 -  Partner with known STI

 -  Inconsistent condom use among persons who are not in a mutually monogamous
 relationship

 -  Ability to understand the consent process and procedures. For minors, the ability to
 obtain consent from parents/legal guardian and assent by minor subjects as applicable
 according to local regulations.

 -  Agree to be available for all study visits including Visit 5 and follow-up Visit 6 and
 comply with follow-up on staff appointment reminders

 -  Negative pregnancy test

 -  Negative CT and GC nucleic acid amplification test (NAAT) at screening or positive CT
 or GC NAAT and receives standard of care (SOC according to CDC or World Health
 Organization [WHO] guidelines) treatment prior to enrollment with subsequent negative
 CT and GC NAAT testing at enrollment visit

 -  Agree to use a woman-controlled method of contraception that is not directly delivered
 to the vaginal mucosa (with the exception of a vaginal ring) throughout the duration
 of the study, such as oral contraceptives, birth control implants, intrauterine
 devices (IUDs), or tubal ligation. Condom use only is not an acceptable form of
 contraception for this study

 -  Able and willing to comply with all study procedures, including the use of eDiaries
 and reporting of all Adverse Events and concomitant medications.

 -  Reports vaginal sexual intercourse with a male partner at least three 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
 investigational product) during course of study

 Exclusion Criteria:

 -  In the opinion of the Investigator, has a history of substance or alcohol abuse in the
 last 12 months or, has issues, conditions, or concerns that may compromise the safety
 of the subject, impact the subject's compliance with the protocol requirements, or
 confound the reliability of the data acquired

 -  Women who have undergone a total hysterectomy (had uterus and cervix removed).
 However, women with subtotal hysterectomy with an intact cervix may be enrolled

 -  Has a history or expectation of noncompliance with medications or intervention
 protocol

 -  Has engaged in sexual vaginal intercourse or douching, or used of any form of vaginal
 suppository or intravaginal device (with the exception of contraceptive vaginal ring
 or tampons) for 24 hours prior to enrollment (may be enrolled at a later date if all
 other criteria are met)

 -  Menstruating at enrollment (may be enrolled at a later date if all other criteria are
 met)

 -  Is currently being treated, or has been treated, for a period of 21 days prior to
 enrollment, with any prohibited antibiotics. The prohibited antibiotics include
 azithromycin, erythromycin, doxycycline, levofloxacin, ofloxacin, ceftriaxone, and
 cefixime.

 -  In the opinion of the Investigator, has signs/symptoms that indicate persistence of CT
 or GC infection diagnosed at screening, new interval infection, and/or a failure to
 comply with or complete the prescribed treatment regimen following a positive
 screening NAAT