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

Sponsor
Evofem Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04553068
Collaborator
(none)
1,730
Enrollment
98
Locations
2
Arms
21.4
Anticipated Duration (Months)
17.7
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 15, 2020
Anticipated Primary Completion Date :
Jul 28, 2022
Anticipated Study Completion Date :
Jul 28, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Demonstrate the proportion of study successes versus failures in the EVO100 and placebo treatment groups [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 [16 weeks]

    Incidence of AEs (descriptive analysis)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes

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

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cahaba Medical Care Birmingham Alabama United States 35218
2 Mobile Obstetrics & Gynecology, P.C. Mobile Alabama United States 36608
3 Marchand OBGYN Mesa Arizona United States 85209
4 Onyx Clinical Research Peoria Arizona United States 85381
5 Precision Trials AZ, LLC Phoenix Arizona United States 85032
6 Applied Research Center of Arkansas Little Rock Arkansas United States 72212
7 Benchmark Research Colton California United States 92324
8 Join Clinical Trials Huntington Park California United States 90255
9 Matrix Clinical Research Los Angeles California United States 90057
10 Dream Team Clinical Research Pomona California United States 91767
11 Empire Clinical Research Pomona California United States 91767
12 University of California, Davis Medical Center Sacramento California United States 95817
13 UC San Diego Health, Womens Health Services La Jolla San Diego California United States 92037
14 Providere Research Inc West Covina California United States 91790
15 Planned Parenthood of Southern New England New Haven Connecticut United States 06511
16 Emerson Clinical Research Institute Washington District of Columbia United States 20011
17 Ideal Clinical Research Aventura Florida United States 33180
18 Encore Medical Research, LLC Hollywood Florida United States 33021
19 Homestead Associates in Research Miami Florida United States 33032
20 South Florida Research Center, Inc. Miami Florida United States 33135
21 Pharmax Research of South Florida, Inc Miami Florida United States 33175
22 US Associates in Research, LLC Miami Florida United States 33175
23 Clintheory Healthcare Miami North Miami Beach Florida United States 33162
24 Healthcare Clinical Data, Inc. North Miami Florida United States 33161
25 Clinical Associates of Orlando, LLC Orlando Florida United States 32819
26 Bioresearch Institute Llc Pembroke Pines Florida United States 33026
27 Precision Clinical Research Sunrise Florida United States 33351
28 Comprehensive Clinical Research, LLC West Palm Beach Florida United States 33409
29 Encore Medical Research of Weston, LLC Weston Florida United States 33331
30 Visionaries Clinical Research, LLC Atlanta Georgia United States 30318
31 Agile Clinical Research Trials, LLC Atlanta Georgia United States 30328
32 Midtown OB GYN Columbus Georgia United States 31901
33 Columbus Regional Research Institute Columbus Georgia United States 31904
34 iResearch Atlanta, LLC Decatur Georgia United States 30030
35 Renew Health Clinical Research Snellville Georgia United States 30078
36 University Women's Health Specialists Honolulu Hawaii United States 96826
37 ASR,LLC Nampa Idaho United States 83687
38 Eagle Clinical Research Chicago Illinois United States 60621
39 Research Network America Chicago Illinois United States 60643
40 DelRicht Research New Orleans Louisiana United States 70124
41 DelRicht Research Prairieville Louisiana United States 70769
42 Continental Clinical Solutions Towson Maryland United States 21204
43 Boston Medical Center/Boston University Medical Campus Boston Massachusetts United States 02118
44 Onyx Clinical Research Flint Michigan United States 48532
45 Planned Parenthood North Central States - Minneapolis Minneapolis Minnesota United States 55408
46 Lintecum and Nickell, P.C. Kansas City Missouri United States 64111
47 Planned Parenthood of the St. Louis Region and Southwest Missouri - Central West End Health Center Saint Louis Missouri United States 63108
48 The Contraceptive Choice Center/Center for Outpatient Health - Women's Health Center Saint Louis Missouri United States 63108
49 Planned Parenthood of Northern, Central and Southern New Jersey Elizabeth New Jersey United States 07201
50 Planned Parenthood of Northern, Central and Southern New Jersey Perth Amboy New Jersey United States 08861
51 Urgent Care Clinical Trials @ AFC Urgent Care-Bronx Bronx New York United States 10465
52 Montefiore Medical Center Bronx New York United States 10467
53 Analyzed Health Clinical Trials New York New York United States 10016
54 NYU Grossman School of Medicine/Bellevue Hospital Center New York New York United States 10016
55 Columbia University Irving Medical Center New York New York United States 10032
56 Circuit Clinical/OB GYN Associates of WNY West Seneca New York United States 14224
57 Accellacare Charlotte North Carolina United States 28209
58 OnSite Clinical Solutions LLC Charlotte North Carolina United States 28277
59 Carolina Institute for Clinical Research Fayetteville North Carolina United States 28303
60 M3 Wake Research, Inc. Raleigh North Carolina United States 27612
61 Across the LifeSpan, PLLC Yanceyville North Carolina United States 27379
62 Seven Hills Clinical Research Group Cincinnati Ohio United States 45242
63 ClinOhio Research Services Columbus Ohio United States 43213
64 Complete Healthcare For Women Columbus Ohio United States 43231
65 DelRicht Research Tulsa Oklahoma United States 74133
66 Planned Parenthood Columbia Willamette Portland Oregon United States 97236
67 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
68 Planned Parenthood Southeastern Pennsylvania Philadelphia Pennsylvania United States 19107
69 UPMC Magee-Womens Hospital, Center for Family Planning Research Pittsburgh Pennsylvania United States 15213
70 Urgent Care Clinical Trials @ AFC Urgent Care-Easley Easley South Carolina United States 29640
71 Urgent Care Clinical Trials @ AFC Urgent Care-Powdersville Powdersville South Carolina United States 29611
72 Urgent Care Clinical Trials @ AFC Urgent Care-Clemson Seneca South Carolina United States 29678
73 WR-Medical Research Center of Memphis, LLC Memphis Tennessee United States 38120
74 Urgent Care Clinical Trials @ Complete Health Care Partners Nashville Tennessee United States 37209
75 Coastal Bend Clinical Research Corpus Christi Texas United States 78413
76 Urgent Care Clinical Trials @City Doc Urgent Care - McKinney Dallas Texas United States 75204
77 AIDS Arms, Inc. DBA Prism Health North Texas Dallas Texas United States 75208
78 Urgent Care Clinical Trials @City Doc Urgent Care-Inwood Dallas Texas United States 75209
79 Cedar Health Research Dallas Texas United States 75251
80 Synergy Groups Medical LLC Houston Texas United States 77036
81 Centex Studies, Inc. Houston Texas United States 77058
82 Synergy Groups Medical LLC Houston Texas United States 77061
83 Cypress Harmony Research, LLC Houston Texas United States 77065
84 Encore Imaging and Medical Research, LLC Houston Texas United States 77065
85 Texas Center for Drug Development, Inc. Houston Texas United States 77081
86 Spring Family Practice Associates PA Houston Texas United States 77379
87 MacArthur Medical Center Irving Texas United States 75062
88 Maximos Ob/Gyn League City Texas United States 77573
89 DCT-McAllen Primary Care Research dba Discovery Clinical Trials McAllen Texas United States 78503
90 Centex Studies, Inc. McAllen Texas United States 78504
91 Synergy Groups Medical LLC Missouri City Texas United States 77459
92 ARC Clinical Research at Kelly Lane Pflugerville Texas United States 78660
93 Storks Research, LLC Sugar Land Texas United States 77479
94 Virginia Women's Health Associates Annandale Virginia United States 22003
95 TPMG Clinical Research Newport News Virginia United States 23606
96 The Group for Women Norfolk Virginia United States 23502
97 MultiCare Health System - Rockwood Clinic Cheney Cheney Washington United States 99004
98 Planned Parenthood of the Great Northwest, Hawai'i, Alaska, Indiana, Kentucky - Tacoma Health Center Tacoma Washington United States 98405

Sponsors and Collaborators

  • Evofem Inc.

Investigators

  • Study Director: Catherine Maher, PhD, Evofem Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Evofem Inc.
ClinicalTrials.gov Identifier:
NCT04553068
Other Study ID Numbers:
  • EVO100-311
First Posted:
Sep 17, 2020
Last Update Posted:
Jun 7, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Chlamydia Infections
Sexually Transmitted Diseases
Gonorrhea

Study Results

No Results Posted as of Jun 7, 2022