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Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection (EVOGUARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04553068
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Evofem Inc.

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

Condition or disease Intervention/treatment Phase
Sexually Transmitted Diseases Gonorrhea Chlamydia Drug: EVO100 Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1730 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Phase 3 Double-blind Placebo-controlled Efficacy Trial of EVO100 Vaginal Gel for the Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : April 22, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Neisseria

Arm Intervention/treatment
Experimental: EVO100 gel
EVO100 vaginal gel, 5 g
Drug: EVO100
EVO100 vaginal gel

Placebo Comparator: Placebo gel
Placebo vaginal gel, 5 g
Drug: Placebo
Placebo vaginal gel




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Evaluate safety of EVO100: Incidence of AEs [ Time Frame: 16 weeks ]
    Incidence of AEs (descriptive analysis)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females Only
Accepts Healthy Volunteers:   Yes
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 within 16 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04553068


Contacts
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Contact: Clinical Operations 858-550-1900 clinicaloperations@evofem.com
Contact: Ellen Harris 858-630-1168 eharris@evofem.com

Locations
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United States, Alabama
Mobile Obstetrics & Gynecology, P.C. Recruiting
Mobile, Alabama, United States, 36608
Contact: P Madonia         
United States, Arizona
Precision Trials AZ, LLC Recruiting
Phoenix, Arizona, United States, 85032
Contact: V Sorkin-Wells         
United States, Florida
American Research Centers of Florida LLC Recruiting
Pembroke Pines, Florida, United States, 33027
Contact: R Lopez         
Precision Clinical Research Recruiting
Sunrise, Florida, United States, 33351
Contact: J Haffizulla         
Comprehensive Clinical Research, LLC Recruiting
West Palm Beach, Florida, United States, 33409
Contact: R Ackerman         
United States, Georgia
Agile Clinical Research Trials, LLC Recruiting
Atlanta, Georgia, United States, 30328
Contact: V Cheekati         
United States, Louisiana
DelRicht Research Recruiting
New Orleans, Louisiana, United States, 70124
Contact: P Dennis         
DelRicht Research Recruiting
Prairieville, Louisiana, United States, 70769
Contact: T. Sanders         
United States, Michigan
Onyx Clinical Research Recruiting
Flint, Michigan, United States, 48532
Contact: V Kalra         
United States, Tennessee
WR-Medical Research Center of Memphis, LLC Recruiting
Memphis, Tennessee, United States, 38120
Contact: B Chappell         
United States, Texas
Texas Center for Drug Development, Inc. Recruiting
Houston, Texas, United States, 77081
Contact: T Becker         
Spring Family Practice Associates PA Recruiting
Houston, Texas, United States, 77379
Contact: S Gorrela         
Maximos Ob/Gyn Recruiting
League City, Texas, United States, 77573
Contact: B Maximos         
Sponsors and Collaborators
Evofem Inc.
Investigators
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Study Director: Kelly Culwell, MD Evofem Inc.
Study Director: Lalitha P Aiyer, MD Evofem Inc.
Additional Information:
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Responsible Party: Evofem Inc.
ClinicalTrials.gov Identifier: NCT04553068    
Other Study ID Numbers: EVO100-311
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chlamydia Infections
Sexually Transmitted Diseases
Gonorrhea
Infection
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Virus Diseases
Neisseriaceae Infections