Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
Condition: Sexually Transmitted Diseases; Gonorrhea; Chlamydia
MeSH terms: Chlamydia Infections; Sexually Transmitted Diseases; Gonorrhea
Intervention: EVO100; Placebo
Intervention description: EVO100 vaginal gel; Placebo vaginal gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1892.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate whether EVO100 vaginal gel prevents the sexual transmission of CT
      and GC infection
    

Eligibility criteria:

        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