Chlamydia Trachomatis InfectionPhase 2/3NCT03107377
Phase 2B/3 Double-blinded Placebo-controlled
A Phase 2/3 study testing EVO100 in people with Chlamydia Trachomatis Infection, run by Evofem Inc. at 50 sites in United States.
Trial summary
Phase 2B double-blind placebo-controlled efficacy trial of EVO100 (previously known as Amphora ® Gel) for the prevention of acquisition of urogenital Chlamydia trachomatis infection Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Trachomatis Infection
- What is being tested?
- EVO100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 860 participants
- Where
- 50 sitesUnited States
- Study dates
- 3 Nov 2017to 22 Aug 2019
- Phase
- Phase 2/3
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects between 18 and 45 years, inclusive
- Ability to understand the consent process and procedures
- Subjects agree to be available for all study visits
- Written informed consent in accordance with institutional guidelines
- Negative pregnancy test
- Negative CT and GC NAAT tests OR positive CT or GC NAAT and receives standard of care (SOC) treatment
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- Agree to use a woman-controlled method of contraception, such as oral contraceptives, vaginal ring, birth control implants, IUDs, or tubal ligation (with the exception of spermicides, diaphragms, or any vaginally applied or inserted products containing nonoxynol-9). Condom use only is not an acceptable form of contraception for this study.
- Able and willing to comply with all study procedures
- Documented (as part of a retrievable medical record) CT or GC infection within 16 weeks prior to enrollment
- Reports vaginal sexual intercourse with a male partner at least 3 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 study product) during course of study
- -
Who cannot join
- Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
- In the opinion of the Investigator, have a history of substance abuse in the last 12 months
- In the opinion of the Investigator, have 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
- Be an Evofem, ClinicalRM, or clinical site employee regardless of direct involvement in research activities, or their close relative
- Pregnant (or actively trying to become pregnant), or breast-feeding
- Women who have undergone a total hysterectomy (had uterus and cervix removed)
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- Inability to provide informed consent
- A subject with a history or expectation of noncompliance with medications or intervention protocol
- Have engaged in sexual intercourse, douching or used of any form of vaginal suppository or intravaginal device 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)
- Women who are currently being treated, or have been treated, for a period of 14 days prior to enrollment, with specific antibiotics known to be used for the treatment of CT or GC:
- Azithromycin
- Erythromycin
- Tetracycline
- Minocycline
- Doxycycline
- Levofloxacin
- Ofloxacin
- Ceftriaxone
- Cefixime
- In the opinion of the Investigator, has signs/symptoms that indicate persistence of chlamydia or gonorrhea 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.
- Women who regularly use douches, vaginal medications, products, or suppositories
- Women who are currently using contraceptive products that are directly delivered to the vaginal mucosa, such as diaphragms, vaginal rings (e.g. NuvaRing®), spermicides, or any vaginally applied or inserted products containing nonoxynol-9.
- Children, pregnant women, prisoners, and other vulnerable populations
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
Bosque Women's Care
Albuquerque, New Mexico, 87109
DM Clinical Research
Alexandria, Louisiana, 71301
California Center for Clinical Research
Arcadia, California, 91007
Premier Family Physicians
Austin, Texas, 78735
Gadolin Research
Beaumont, Texas, 77701
MedPharmics, LLD
Biloxi, Mississippi, 39531
Hope Clinical Research
Canoga Park, California, 91303
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612
University of Cincinnati Physicians
Cincinnati, Ohio, 41073
Columbus Regional Research Institute - IACT Health
Columbus, Georgia, 31901
CityDoc Urgent Care
Dallas, Texas, 75204
AFC Urgent Care Denver
Denver, Colorado, 80202
Research Network America
Houston, Texas, 77021
Centex Studios, Inc.
Houston, Texas, 77058
Discovery MM Services, Inc.
Houston, Texas, 77061
S.E.Tx. Family Planning and Cancer Screening (SOGA)
Houston, Texas, 77074
Texas Center for Drug Development, Inc.
Houston, Texas, 77081
United Clinical Research
Huntington Park, California, 90255
University of MS Medical Center
Jackson, Mississippi, 39213
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Nevada Obstetrical Charity Clinic
Las Vegas, Nevada, 89106
Precision Clinical Research
Lauderdale Lakes, Florida, 33319
Renew Health Clinical Research, LLC
Lawrenceville, Georgia, 30046
Adams Patterson OB/GYN, Medical Research Center of Memphis
Memphis, Tennessee, 38120
South Florida Research Center, Inc.
Miami, Florida, 33135
Panax Clinical Research
Miami Lakes, Florida, 33014
Global Health Research Center
Miami Lakes, Florida, 33016
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Mobile OB-GYN, PC
Mobile, Alabama, 36608
ASR, LLC
Nampa, Idaho, 83687
Planned Parenthood of Southern New England
New Haven, Connecticut, 06511
DelRicht Research
New Orleans, Louisiana, 70124
The Group for Women
Norfolk, Virginia, 23502
Planned Parenthood Southeastern Pennsylvania
Philadelphia, Pennsylvania, 19107
MedPharmics, LLC
Phoenix, Arizona, 85015
Precision Trials AZ, LLC
Phoenix, Arizona, 85032
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213-3180
North Texas Family Medicine
Plano, Texas, 75093
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Meridian Clinical Research
Richmond Hill, Georgia, 31324
Valley OB-GYN
Saginaw, Michigan, 48602
PMG Research of Salisbury
Salisbury, North Carolina, 28144
Neere Bhatia, MD OB/GYN
San Antonio, Texas, 78212
Medical Center for Clinical Research - Wake Research
San Diego, California, 92108
Optimus Medical Group, Inc.
San Francisco, California, 94102
Physician Care Clinical Research LLC
Sarasota, Florida, 34239
Eclipse Clinical Research
Tucson, Arizona, 85745
Invocare Clinical Research Center
West Columbia, South Carolina, 29169
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
PMG Research, Inc. - Wilmington Health
Wilmington, North Carolina, 28401
About this study
Official title: Phase 2B Double-blind Placebo-controlled Efficacy Trial of EVO100 (Previously Known as Amphora ® Gel) for the Prevention of Acquisition of Urogenital Chlamydia Trachomatis Infection
Phase 2B double-blind placebo-controlled efficacy trial of EVO100 (previously known as Amphora ® Gel) for the prevention of acquisition of urogenital Chlamydia trachomatis infection
Read the detailed description
Primary: To determine if intravaginal EVO100 reduces the risk of urogenital Chlamydia trachomatis (CT) infection.
Secondary: To determine if intravaginal EVO100 reduces the risk of urogenital Neisseria gonorrhoeae (GC) infection.
Exploratory:To determine if EVO100 use rate (subject adherence to instructed use) has an effect on proportion of subjects who experience CT or GC infection during the study intervention period.
Primary Outcome Measures: Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT).
Secondary Outcome Measures: Proportion of subjects who experience urogenital GC infection during the study intervention period (incident infection of GC).
Exploratory Outcome Measures:
- Compliance with EVO100 usage during study (rate of product use adherence).
- Sensitivity analyses of the primary parameter (proportion of subjects who experience at least one CT or GC infection during the study intervention period) will be performed for the following:
- Subjects with ≥20%, ≥40%, ≥60% and ≥80% product use adherence
- Subject Satisfaction
- Sexual satisfaction
- Conditions
- Chlamydia Trachomatis Infection
- Being tested
- EVO100, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVO100Drug
5 g dose applied up to 1 hour prior to coitus
PlaceboDrug
5 g dose applied up to 1 hour prior to coitus
| Study group | Role | What they receive |
|---|---|---|
| EVO100 | Active comparator | A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse. Receives: Drug: EVO100 |
| Placebo | Placebo comparator | An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urogenital CT Infection
Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT).
Measured: 16 weeks
Secondary outcomes (1)
Urogenital GC Infection
Proportion of subjects who experience urogenital GC infection during the study intervention period (incident infection of GC).
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 posted11 Apr 2017
- Study start3 Nov 2017
- Primary completion22 Aug 2019
- Study completion22 Aug 2019
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 Chlamydia Trachomatis InfectionStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 2B double-blind placebo-controlled efficacy trial of EVO100 for the prevention of acquisition of urogenital Chlamydia trachomatis infection
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 860 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evofem Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Management, Inc.
- Responsible party
- Sponsor
- Investigators
- Kelly Culwell, MD, Study director, Evofem Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107377
- Sponsor's protocol ID
- EVO-003
- Status last verified
- Jul 2020
- First submitted
- 29 Mar 2017
- Last updated
- 12 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Chappell BT, Mena LA, Maximos B, Mollan S, Culwell K, Howard B. EVO100 prevents chlamydia and gonorrhea in women at high risk of infection. Am J Obstet Gynecol. 2021 Aug;225(2):162.e1-162.e14. doi: 10.1016/j.ajog.2021.03.005. Epub 2021 Mar 8.
PubMed 33705748
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2B Double-blind Placebo-controlled Efficacy Trial of EVO100 (Previously Known as Amphora ® Gel) for the Prevention of Acquisition of Urogenital Chlamydia Trachomatis Infection
- ClinicalTrials.gov ID
- NCT03107377
- Acronym / sponsor ID
- EVO-003
- Conditions
- Chlamydia Trachomatis Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 860 participants (actual)
- Lead sponsor
- Evofem Inc.Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Management, Inc.
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Posted 12 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2B double-blind placebo-controlled efficacy trial of EVO100 (previously known as Amphora ® Gel) for the prevention of acquisition of urogenital Chlamydia trachomatis infection
Detailed description
Primary: To determine if intravaginal EVO100 reduces the risk of urogenital Chlamydia trachomatis (CT) infection.
Secondary: To determine if intravaginal EVO100 reduces the risk of urogenital Neisseria gonorrhoeae (GC) infection.
Exploratory:To determine if EVO100 use rate (subject adherence to instructed use) has an effect on proportion of subjects who experience CT or GC infection during the study intervention period.
Primary Outcome Measures: Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT).
Secondary Outcome Measures: Proportion of subjects who experience urogenital GC infection during the study intervention period (incident infection of GC).
Exploratory Outcome Measures:
- Compliance with EVO100 usage during study (rate of product use adherence).
- Sensitivity analyses of the primary parameter (proportion of subjects who experience at least one CT or GC infection during the study intervention period) will be performed for the following:
- Subjects with ≥20%, ≥40%, ≥60% and ≥80% product use adherence
- Subject Satisfaction
- Sexual satisfaction
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 2B double-blind placebo-controlled efficacy trial of EVO100 for the prevention of acquisition of urogenital Chlamydia trachomatis infection
| Arm | Type | Receives |
|---|---|---|
| EVO100 | Active comparator | Drug: EVO100A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse. |
| Placebo | Placebo comparator | Drug: PlaceboAn isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy female subjects between 18 and 45 years, inclusive
- Ability to understand the consent process and procedures
- Subjects agree to be available for all study visits
- Written informed consent in accordance with institutional guidelines
- Negative pregnancy test
Key exclusion criteria (24 listed)
- Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
- In the opinion of the Investigator, have a history of substance abuse in the last 12 months
- In the opinion of the Investigator, have 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
- Be an Evofem, ClinicalRM, or clinical site employee regardless of direct involvement in research activities, or their close relative
- Pregnant (or actively trying to become pregnant), or breast-feeding
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 |
|---|---|---|
| EVO1005 g dose applied up to 1 hour prior to coitus | Drug | EVO100 |
| Placebo5 g dose applied up to 1 hour prior to coitus | Drug | Placebo |
Primary outcome
Urogenital CT Infection
Time frame: 16 weeks
Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT).
1 secondary outcome
Urogenital GC Infection
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 12 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33705748Chappell BT, Mena LA, Maximos B, Mollan S, Culwell K, Howard B. EVO100 prevents chlamydia and gonorrhea in women at high risk of infection. Am J Obstet Gynecol. 2021 Aug;225(2):162.e1-162.e14. doi: 10.1016/j.ajog.2021.03.005. Epub 2021 Mar 8.
- Individual participant dataSharing planned: Yes
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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.
Kelly Culwell, MD study director
Evofem Inc.
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EVO100 in people with Chlamydia Trachomatis Infection, run by Evofem Inc. at 50 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 12 inclusion and 24 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 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 12 Aug 2020). 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?
Urogenital CT Infection (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 NCT03107377, 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 12 Aug 2020.