Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
860 participants
INTERVENTIONAL
2017-11-03
2019-08-22
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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
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
Interventions
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EVO100
5 g dose applied up to 1 hour prior to coitus
Placebo
5 g dose applied up to 1 hour prior to coitus
Eligibility Criteria
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Inclusion Criteria
2. Ability to understand the consent process and procedures
3. Subjects agree to be available for all study visits
4. Written informed consent in accordance with institutional guidelines
5. Negative pregnancy test
6. Negative CT and GC NAAT tests OR positive CT or GC NAAT and receives standard of care (SOC) treatment
7. 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.
8. Able and willing to comply with all study procedures
9. Documented (as part of a retrievable medical record) CT or GC infection within 16 weeks prior to enrollment
10. 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
11. Agree to abstain from douching or any form of vaginal suppository use (other than study product) during course of study
\-
Exclusion Criteria
2. In the opinion of the Investigator, have a history of substance abuse in the last 12 months
3. 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
4. Be an Evofem, ClinicalRM, or clinical site employee regardless of direct involvement in research activities, or their close relative
5. Pregnant (or actively trying to become pregnant), or breast-feeding
6. Women who have undergone a total hysterectomy (had uterus and cervix removed)
7. Inability to provide informed consent
8. A subject with a history or expectation of noncompliance with medications or intervention protocol
9. 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)
10. Menstruating at enrollment (may be enrolled at a later date if all other criteria are met)
11. 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:
1. Azithromycin
2. Erythromycin
3. Tetracycline
4. Minocycline
5. Doxycycline
6. Levofloxacin
7. Ofloxacin
8. Ceftriaxone
9. Cefixime
12. 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.
13. Women who regularly use douches, vaginal medications, products, or suppositories
14. 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.
15. Children, pregnant women, prisoners, and other vulnerable populations
18 Years
45 Years
FEMALE
Yes
Sponsors
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Clinical Research Management, Inc.
INDUSTRY
Evofem Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kelly Culwell, MD
Role: STUDY_DIRECTOR
Evofem Inc.
Locations
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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Mobile OB-GYN, PC
Mobile, Alabama, United States
MedPharmics, LLC
Phoenix, Arizona, United States
Precision Trials AZ, LLC
Phoenix, Arizona, United States
Eclipse Clinical Research
Tucson, Arizona, United States
California Center for Clinical Research
Arcadia, California, United States
Hope Clinical Research
Canoga Park, California, United States
United Clinical Research
Huntington Park, California, United States
Medical Center for Clinical Research - Wake Research
San Diego, California, United States
Optimus Medical Group, Inc.
San Francisco, California, United States
AFC Urgent Care Denver
Denver, Colorado, United States
Planned Parenthood of Southern New England
New Haven, Connecticut, United States
Precision Clinical Research
Lauderdale Lakes, Florida, United States
South Florida Research Center, Inc.
Miami, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Global Health Research Center
Miami Lakes, Florida, United States
Physician Care Clinical Research LLC
Sarasota, Florida, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States
Columbus Regional Research Institute - IACT Health
Columbus, Georgia, United States
Renew Health Clinical Research, LLC
Lawrenceville, Georgia, United States
Meridian Clinical Research
Richmond Hill, Georgia, United States
ASR, LLC
Nampa, Idaho, United States
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States
DM Clinical Research
Alexandria, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
Valley OB-GYN
Saginaw, Michigan, United States
MedPharmics, LLD
Biloxi, Mississippi, United States
University of MS Medical Center
Jackson, Mississippi, United States
Nevada Obstetrical Charity Clinic
Las Vegas, Nevada, United States
Bosque Women's Care
Albuquerque, New Mexico, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
PMG Research, Inc. - Wilmington Health
Wilmington, North Carolina, United States
University of Cincinnati Physicians
Cincinnati, Ohio, United States
Planned Parenthood Southeastern Pennsylvania
Philadelphia, Pennsylvania, United States
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Invocare Clinical Research Center
West Columbia, South Carolina, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Adams Patterson OB/GYN, Medical Research Center of Memphis
Memphis, Tennessee, United States
Premier Family Physicians
Austin, Texas, United States
Gadolin Research
Beaumont, Texas, United States
CityDoc Urgent Care
Dallas, Texas, United States
Research Network America
Houston, Texas, United States
Centex Studios, Inc.
Houston, Texas, United States
Discovery MM Services, Inc.
Houston, Texas, United States
S.E.Tx. Family Planning and Cancer Screening (SOGA)
Houston, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
North Texas Family Medicine
Plano, Texas, United States
Neere Bhatia, MD OB/GYN
San Antonio, Texas, United States
The Group for Women
Norfolk, Virginia, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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EVO-003
Identifier Type: -
Identifier Source: org_study_id
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