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Trial record 1 of 1 for:    EVO100-311
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Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection (EVOGUARD)

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ClinicalTrials.gov Identifier: NCT04553068
Recruitment Status : Active, not recruiting
First Posted : September 17, 2020
Last Update Posted : June 7, 2022
Sponsor:
Information provided by (Responsible Party):
Evofem Inc.

Tracking Information
First Submitted Date  ICMJE September 11, 2020
First Posted Date  ICMJE September 17, 2020
Last Update Posted Date June 7, 2022
Actual Study Start Date  ICMJE October 15, 2020
Estimated Primary Completion Date July 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2020)
Demonstrate the proportion of study successes versus failures in the EVO100 and placebo treatment groups [ Time Frame: 16 weeks ]
Proportion of subjects who are defined study successes vs study failures among the intervention groups with success defined as subjects completing the trial to Visit 5 without any CT or GC infection and no usage of prohibited antibiotics during the study.
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2020)
Demonstrate efficacy of EVO100 compared with Placebo [ Time Frame: 16 weeks ]
Proportion of subjects who are defined study successes vs study failures among the intervention groups with success defined as subjects completing the trial to Visit 5 without any CT or GC infection and no usage of prohibited antibiotics during the study.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2020)
Evaluate safety of EVO100: Incidence of AEs [ Time Frame: 16 weeks ]
Incidence of AEs (descriptive analysis)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
Official Title  ICMJE Phase 3 Double-blind Placebo-controlled Efficacy Trial of EVO100 Vaginal Gel for the Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
Brief Summary This study will evaluate whether EVO100 vaginal gel prevents the sexual transmission of CT and GC infection
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Sexually Transmitted Diseases
  • Gonorrhea
  • Chlamydia
Intervention  ICMJE
  • Drug: EVO100
    EVO100 vaginal gel
  • Drug: Placebo
    Placebo vaginal gel
Study Arms  ICMJE
  • Experimental: EVO100 gel
    EVO100 vaginal gel, 5 g
    Intervention: Drug: EVO100
  • Placebo Comparator: Placebo gel
    Placebo vaginal gel, 5 g
    Intervention: Drug: Placebo
Publications * Thomas MA, Morlock R, Dart C, Howard B. Sexual Satisfaction Results With the Vaginal pH Modulator From the Phase 3 AMPOWER Study. J Sex Med. 2022 Jun;19(6):975-982. doi: 10.1016/j.jsxm.2022.03.221. Epub 2022 Apr 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 16, 2020)
1730
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 28, 2022
Estimated Primary Completion Date July 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Females Only
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04553068
Other Study ID Numbers  ICMJE EVO100-311
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Evofem Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Evofem Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Catherine Maher, PhD Evofem Inc.
PRS Account Evofem Inc.
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP