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| Name | Class |
|---|---|
| Clinical Research Management, Inc. | INDUSTRY |
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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVO100 | Drug | 5 g dose applied up to 1 hour prior to coitus |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Urogenital CT Infection | Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT). | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Urogenital GC Infection | Proportion of subjects who experience urogenital GC infection during the study intervention period (incident infection of GC). | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance With EVO100 and Sensitivity Analyses (Part I) | Summary of Coital Events during treatment | 16 weeks |
| Subject Satisfaction With Product | The proportion of subjects who experienced at least one CT infection during the study Intervention Period was summarized by treatment group using the mITT population and subject adherence rates. |
Inclusion Criteria:
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
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
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Exclusion Criteria:
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)
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:
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
844 female subjects, ages 18-45.
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Culwell, MD | Evofem Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | United States | ||
| Mobile OB-GYN, PC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33705748 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | EVO100 | 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. EVO100: 5 g dose applied up to 1 hour prior to coitus |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2019 | Jun 9, 2020 |
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Phase 2B double-blind placebo-controlled efficacy trial of EVO100 for the prevention of acquisition of urogenital Chlamydia trachomatis infection
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double-blind placebo-controlled efficacy trial of EVO100
| Drug |
5 g dose applied up to 1 hour prior to coitus |
|
| 16 weeks |
| Sexual Satisfaction | The proportion of subjects who experienced at least one GC infection during the study Intervention Period was summarized by treatment group using the mITT population and subject adherence rates. | 16 weeks |
| Compliance With EVO100 and Sensitivity Analyses | The proportion of subjects who experienced at least one CT infection during the study Intervention Period was summarized by treatment group using the mITT population and subject adherence rates. | 16 weeks |
| Compliance With EVO100 and Sensitivity Analyses | The proportion of subjects who experienced at least one GC infection during the study Intervention Period was summarized by treatment group using the mITT population and subject adherence rates. | 16 weeks |
| Compliance With EVO100 and Sensitivity Analyses (Part II) | Summary of number of applicators used via eDiary | 16 weeks |
| Compliance With EVO100 and Sensitivity Analyses (Part III) | Study product adherence | 16 weeks |
| Mobile |
| Alabama |
| 36608 |
| United States |
| MedPharmics, LLC | Phoenix | Arizona | 85015 | United States |
| Precision Trials AZ, LLC | Phoenix | Arizona | 85032 | United States |
| Eclipse Clinical Research | Tucson | Arizona | 85745 | United States |
| California Center for Clinical Research | Arcadia | California | 91007 | United States |
| Hope Clinical Research | Canoga Park | California | 91303 | United States |
| United Clinical Research | Huntington Park | California | 90255 | United States |
| Medical Center for Clinical Research - Wake Research | San Diego | California | 92108 | United States |
| Optimus Medical Group, Inc. | San Francisco | California | 94102 | United States |
| AFC Urgent Care Denver | Denver | Colorado | 80202 | United States |
| Planned Parenthood of Southern New England | New Haven | Connecticut | 06511 | United States |
| Precision Clinical Research | Lauderdale Lakes | Florida | 33319 | United States |
| South Florida Research Center, Inc. | Miami | Florida | 33135 | United States |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | United States |
| Global Health Research Center | Miami Lakes | Florida | 33016 | United States |
| Physician Care Clinical Research LLC | Sarasota | Florida | 34239 | United States |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | United States |
| Columbus Regional Research Institute - IACT Health | Columbus | Georgia | 31901 | United States |
| Renew Health Clinical Research, LLC | Lawrenceville | Georgia | 30046 | United States |
| Meridian Clinical Research | Richmond Hill | Georgia | 31324 | United States |
| ASR, LLC | Nampa | Idaho | 83687 | United States |
| John H. Stroger Jr. Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| DM Clinical Research | Alexandria | Louisiana | 71301 | United States |
| DelRicht Research | New Orleans | Louisiana | 70124 | United States |
| Valley OB-GYN | Saginaw | Michigan | 48602 | United States |
| MedPharmics, LLD | Biloxi | Mississippi | 39531 | United States |
| University of MS Medical Center | Jackson | Mississippi | 39213 | United States |
| Nevada Obstetrical Charity Clinic | Las Vegas | Nevada | 89106 | United States |
| Bosque Women's Care | Albuquerque | New Mexico | 87109 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| PMG Research of Salisbury | Salisbury | North Carolina | 28144 | United States |
| PMG Research, Inc. - Wilmington Health | Wilmington | North Carolina | 28401 | United States |
| University of Cincinnati Physicians | Cincinnati | Ohio | 41073 | United States |
| Planned Parenthood Southeastern Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213-3180 | United States |
| Invocare Clinical Research Center | West Columbia | South Carolina | 29169 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Adams Patterson OB/GYN, Medical Research Center of Memphis | Memphis | Tennessee | 38120 | United States |
| Premier Family Physicians | Austin | Texas | 78735 | United States |
| Gadolin Research | Beaumont | Texas | 77701 | United States |
| CityDoc Urgent Care | Dallas | Texas | 75204 | United States |
| Research Network America | Houston | Texas | 77021 | United States |
| Centex Studios, Inc. | Houston | Texas | 77058 | United States |
| Discovery MM Services, Inc. | Houston | Texas | 77061 | United States |
| S.E.Tx. Family Planning and Cancer Screening (SOGA) | Houston | Texas | 77074 | United States |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | United States |
| North Texas Family Medicine | Plano | Texas | 75093 | United States |
| Neere Bhatia, MD OB/GYN | San Antonio | Texas | 78212 | United States |
| The Group for Women | Norfolk | Virginia | 23502 | United States |
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. Placebo: 5 g dose applied up to 1 hour prior to coitus |
| COMPLETED |
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| NOT COMPLETED |
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ITT Population
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| ID | Title | Description |
|---|---|---|
| BG000 | EVO100 | 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. EVO100l: 5 g dose applied up to 1 hour prior to coitus |
| BG001 | Placebo | 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. Placebo: 5 g dose applied up to 1 hour prior to coitus |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Urogenital CT Infection | Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT). | mITT Population - All CT Analysis Eligible Subjects | Posted | Count of Participants | Participants | 16 weeks |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Urogenital GC Infection | Proportion of subjects who experience urogenital GC infection during the study intervention period (incident infection of GC). | mITT Population - All GC Analysis Eligible Subjects | Posted | Count of Participants | Participants | 16 weeks |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Compliance With EVO100 and Sensitivity Analyses (Part I) | Summary of Coital Events during treatment | mITT population | Posted | Mean | Standard Deviation | Coital Events | 16 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Subject Satisfaction With Product | The proportion of subjects who experienced at least one CT infection during the study Intervention Period was summarized by treatment group using the mITT population and subject adherence rates. | Subject Satisfaction by Visit (mITT population) | Posted | Count of Participants | Participants | 16 weeks |
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| Other Pre-specified | Sexual Satisfaction | The proportion of subjects who experienced at least one GC infection during the study Intervention Period was summarized by treatment group using the mITT population and subject adherence rates. | Subjects sexual satisfaction by Visit - mITT population | Posted | Count of Participants | Participants | 16 weeks |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Compliance With EVO100 and Sensitivity Analyses | The proportion of subjects who experienced at least one CT infection during the study Intervention Period was summarized by treatment group using the mITT population and subject adherence rates. | mITT Population - All CT Analysis Eligible Subjects | Posted | Count of Participants | Participants | 16 weeks |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Compliance With EVO100 and Sensitivity Analyses | The proportion of subjects who experienced at least one GC infection during the study Intervention Period was summarized by treatment group using the mITT population and subject adherence rates. | mITT Population - All GC Analysis Eligible Subjects | Posted | Count of Participants | Participants | 16 weeks |
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| Other Pre-specified | Compliance With EVO100 and Sensitivity Analyses (Part II) | Summary of number of applicators used via eDiary | mITT population | Posted | Mean | Standard Deviation | Number of Applicators | 16 weeks |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Compliance With EVO100 and Sensitivity Analyses (Part III) | Study product adherence | mITT population | Posted | Mean | Standard Deviation | % of sex acts where study product used | 16 weeks |
|
|
20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EVO100 | 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. EVO100: 5 g dose applied up to 1 hour prior to coitus | 0 | 376 | 2 | 376 | 62 | 376 |
| EG001 | Placebo | 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. Placebo: 5 g dose applied up to 1 hour prior to coitus | 0 | 388 | 3 | 388 | 46 | 388 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacterial Vaginosis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infections | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Vulvovaginal Candidiasis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Vaginal Discharge | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
|
For the Adverse Event Section: There were no All-Cause Mortalities to Report
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Evofem | 858-550-1900 | kculwell@evofem.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 24, 2019 | Jun 9, 2020 | SAP_001.pdf |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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