Phase 2B/3 Double-blinded Placebo-controlled
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
1 other identifier
interventional
860
1 country
50
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2017
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2017
CompletedFirst Posted
Study publicly available on registry
April 11, 2017
CompletedStudy Start
First participant enrolled
November 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2019
CompletedResults Posted
Study results publicly available
August 12, 2020
CompletedAugust 12, 2020
July 1, 2020
1.8 years
March 29, 2017
June 9, 2020
July 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Urogenital CT Infection
Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT).
16 weeks
Secondary Outcomes (1)
Urogenital GC Infection
16 weeks
Other Outcomes (7)
Compliance With EVO100 and Sensitivity Analyses (Part I)
16 weeks
Subject Satisfaction With Product
16 weeks
Sexual Satisfaction
16 weeks
- +4 more other outcomes
Study Arms (2)
EVO100
ACTIVE COMPARATORA 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 COMPARATORAn 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- Azithromycin
- Erythromycin
- Tetracycline
- Minocycline
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Evofem Inc.lead
- Clinical Research Management, Inc.collaborator
Study Sites (50)
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Mobile OB-GYN, PC
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
Related Publications (1)
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.
PMID: 33705748DERIVED
Limitations and Caveats
For the Adverse Event Section: There were no All-Cause Mortalities to Report
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Evofem
Study Officials
- STUDY DIRECTOR
Kelly Culwell, MD
Evofem Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- double-blind placebo-controlled efficacy trial of EVO100
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2017
First Posted
April 11, 2017
Study Start
November 3, 2017
Primary Completion
August 22, 2019
Study Completion
August 22, 2019
Last Updated
August 12, 2020
Results First Posted
August 12, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share