Sexually Transmitted DiseasesPhase 3EVOGUARDNCT04553068
Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
A Phase 3 study testing EVO100 in people with Sexually Transmitted Diseases and Gonorrhea, run by Evofem Inc. at 98 sites in United States.
Trial summary
This study will evaluate whether EVO100 vaginal gel prevents the sexual transmission of CT and GC infection Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases, Gonorrhea, Chlamydia
- What is being tested?
- EVO100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,892 participants
- Where
- 98 sitesUnited States
- Study dates
- 15 Oct 2020to 28 Jul 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet both of the following criteria:
- 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
Show all 23Show fewer
- Partner with known sexually transmitted infection (STI)
- Inconsistent condom use among persons who are not in a mutually monogamous relationship
- 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
Who cannot join
- 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
Trial locations and contacts
98 sites in 1 country.
98 sites in 1 country
United States98 sites
Virginia Women's Health Associates
Annandale, Virginia, 22003
Visionaries Clinical Research, LLC
Atlanta, Georgia, 30318
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328
Ideal Clinical Research
Aventura, Florida, 33180
Cahaba Medical Care
Birmingham, Alabama, 35218
Boston Medical Center/Boston University Medical Campus
Boston, Massachusetts, 02118
Accellacare
Charlotte, North Carolina, 28209
OnSite Clinical Solutions LLC
Charlotte, North Carolina, 28277
MultiCare Health System - Rockwood Clinic Cheney
Cheney, Washington, 99004
Eagle Clinical Research
Chicago, Illinois, 60621
Research Network America
Chicago, Illinois, 60643
Seven Hills Clinical Research Group
Cincinnati, Ohio, 45242
Benchmark Research
Colton, California, 92324
Midtown OB GYN
Columbus, Georgia, 31901
Columbus Regional Research Institute
Columbus, Georgia, 31904
ClinOhio Research Services
Columbus, Ohio, 43213
Complete Healthcare For Women
Columbus, Ohio, 43231
Coastal Bend Clinical Research
Corpus Christi, Texas, 78413
Urgent Care Clinical Trials @City Doc Urgent Care - McKinney
Dallas, Texas, 75204
AIDS Arms, Inc. DBA Prism Health North Texas
Dallas, Texas, 75208
Urgent Care Clinical Trials @City Doc Urgent Care-Inwood
Dallas, Texas, 75209
Cedar Health Research
Dallas, Texas, 75251
iResearch Atlanta, LLC
Decatur, Georgia, 30030
Urgent Care Clinical Trials @ AFC Urgent Care-Easley
Easley, South Carolina, 29640
Planned Parenthood of Northern, Central and Southern New Jersey
Elizabeth, New Jersey, 07201
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28303
Onyx Clinical Research
Flint, Michigan, 48532
Encore Medical Research, LLC
Hollywood, Florida, 33021
University Women's Health Specialists
Honolulu, Hawaii, 96826
Synergy Groups Medical LLC
Houston, Texas, 77036
Centex Studies, Inc.
Houston, Texas, 77058
Synergy Groups Medical LLC
Houston, Texas, 77061
Cypress Harmony Research, LLC
Houston, Texas, 77065
Encore Imaging and Medical Research, LLC
Houston, Texas, 77065
Texas Center for Drug Development, Inc.
Houston, Texas, 77081
Spring Family Practice Associates PA
Houston, Texas, 77379
Join Clinical Trials
Huntington Park, California, 90255
MacArthur Medical Center
Irving, Texas, 75062
Lintecum and Nickell, P.C.
Kansas City, Missouri, 64111
Maximos Ob/Gyn
League City, Texas, 77573
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
Matrix Clinical Research
Los Angeles, California, 90057
DCT-McAllen Primary Care Research dba Discovery Clinical Trials
McAllen, Texas, 78503
Centex Studies, Inc.
McAllen, Texas, 78504
WR-Medical Research Center of Memphis, LLC
Memphis, Tennessee, 38120
Marchand OBGYN
Mesa, Arizona, 85209
Homestead Associates in Research
Miami, Florida, 33032
South Florida Research Center, Inc.
Miami, Florida, 33135
Pharmax Research of South Florida, Inc
Miami, Florida, 33175
US Associates in Research, LLC
Miami, Florida, 33175
Planned Parenthood North Central States - Minneapolis
Minneapolis, Minnesota, 55408
Synergy Groups Medical LLC
Missouri City, Texas, 77459
Mobile Obstetrics & Gynecology, P.C.
Mobile, Alabama, 36608
ASR,LLC
Nampa, Idaho, 83687
Urgent Care Clinical Trials @ Complete Health Care Partners
Nashville, Tennessee, 37209
Planned Parenthood of Southern New England
New Haven, Connecticut, 06511
DelRicht Research
New Orleans, Louisiana, 70124
Analyzed Health Clinical Trials
New York, New York, 10016
NYU Grossman School of Medicine/Bellevue Hospital Center
New York, New York, 10016
Columbia University Irving Medical Center
New York, New York, 10032
TPMG Clinical Research
Newport News, Virginia, 23606
The Group for Women
Norfolk, Virginia, 23502
Healthcare Clinical Data, Inc.
North Miami, Florida, 33161
Clintheory Healthcare Miami
North Miami Beach, Florida, 33162
Clinical Associates of Orlando, LLC
Orlando, Florida, 32819
Bioresearch Institute Llc
Pembroke Pines, Florida, 33026
Onyx Clinical Research
Peoria, Arizona, 85381
Planned Parenthood of Northern, Central and Southern New Jersey
Perth Amboy, New Jersey, 08861
ARC Clinical Research at Kelly Lane
Pflugerville, Texas, 78660
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Planned Parenthood Southeastern Pennsylvania
Philadelphia, Pennsylvania, 19107
Precision Trials AZ, LLC
Phoenix, Arizona, 85032
UPMC Magee-Womens Hospital, Center for Family Planning Research
Pittsburgh, Pennsylvania, 15213
Dream Team Clinical Research
Pomona, California, 91767
Empire Clinical Research
Pomona, California, 91767
Planned Parenthood Columbia Willamette
Portland, Oregon, 97236
Urgent Care Clinical Trials @ AFC Urgent Care-Powdersville
Powdersville, South Carolina, 29611
DelRicht Research
Prairieville, Louisiana, 70769
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612
University of California, Davis Medical Center
Sacramento, California, 95817
UC San Diego Health, Womens Health Services La Jolla
San Diego, California, 92037
Urgent Care Clinical Trials @ AFC Urgent Care-Clemson
Seneca, South Carolina, 29678
Renew Health Clinical Research
Snellville, Georgia, 30078
Planned Parenthood of the St. Louis Region and Southwest Missouri - Central West End Health Center
St Louis, Missouri, 63108
The Contraceptive Choice Center/Center for Outpatient Health - Women's Health Center
St Louis, Missouri, 63108
Storks Research, LLC
Sugar Land, Texas, 77479
Precision Clinical Research
Sunrise, Florida, 33351
Planned Parenthood of the Great Northwest, Hawai'i, Alaska, Indiana, Kentucky - Tacoma Health Center
Tacoma, Washington, 98405
Urgent Care Clinical Trials @ AFC Urgent Care-Bronx
The Bronx, New York, 10465
Montefiore Medical Center
The Bronx, New York, 10467
Continental Clinical Solutions
Towson, Maryland, 21204
DelRicht Research
Tulsa, Oklahoma, 74133
Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20011
Providere Research Inc
West Covina, California, 91790
Comprehensive Clinical Research, LLC
West Palm Beach, Florida, 33409
Circuit Clinical/OB GYN Associates of WNY
West Seneca, New York, 14224
Encore Medical Research of Weston, LLC
Weston, Florida, 33331
Across the LifeSpan, PLLC
Yanceyville, North Carolina, 27379
About this study
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
This study will evaluate whether EVO100 vaginal gel prevents the sexual transmission of CT and GC infection
Read the 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.
- Conditions
- Sexually Transmitted Diseases, Gonorrhea, Chlamydia
- Being tested
- EVO100, Placebo
- Medical subject headings
- Sexually Transmitted Diseases, Gonorrhea, Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVO100Drug
EVO100 vaginal gel
PlaceboDrug
Placebo vaginal gel
| Study group | Role | What they receive |
|---|---|---|
| EVO100 gel | Experimental | EVO100 vaginal gel, 5 g Receives: Drug: EVO100 |
| Placebo gel | Placebo comparator | Placebo vaginal gel, 5 g Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Study Successes in the EVO100 and Placebo Treatment Groups
Percentage of subjects who are defined study successes 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.
Measured: 16 weeks
Secondary outcomes (1)
Evaluate Safety of EVO100: AEs
Descriptive analysis of AEs
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start15 Oct 2020
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,892 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evofem Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Maher, PhD, Study director, Evofem Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553068
- Sponsor's protocol ID
- EVO100-311
- Acronym
- EVOGUARD
- Status last verified
- Jan 2024
- First submitted
- 11 Sep 2020
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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.
PubMed 35418329
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04553068
- Acronym / sponsor ID
- EVOGUARD / EVO100-311
- Conditions
- Sexually Transmitted Diseases, Gonorrhea, Chlamydia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,892 participants (actual)
- Lead sponsor
- Evofem Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVO100 gel | Experimental | Drug: EVO100EVO100 vaginal gel, 5 g |
| Placebo gel | Placebo comparator | Drug: PlaceboPlacebo vaginal gel, 5 g |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Subjects must meet both of the following criteria:
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVO100EVO100 vaginal gel | Drug | EVO100 gel |
| PlaceboPlacebo vaginal gel | Drug | Placebo gel |
Primary outcome
Percentage of Study Successes in the EVO100 and Placebo Treatment Groups
Time frame: 16 weeks
Percentage of subjects who are defined study successes 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.
1 secondary outcome
Evaluate Safety of EVO100: AEs
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35418329Thomas 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.
Related trials for Sexually Transmitted Diseases
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Maher, PhD study director
Evofem Inc.
98 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EVO100 in people with Sexually Transmitted Diseases and Gonorrhea, run by Evofem Inc. at 98 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Study Successes in the EVO100 and Placebo Treatment Groups (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04553068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.