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

Status: Completed
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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

Locations
United States
Alabama
Coastal Clinical Research, Inc.
Mobile
Mobile OB-GYN, PC
Mobile
Arizona
MedPharmics, LLC
Phoenix
Precision Trials AZ, LLC
Phoenix
Eclipse Clinical Research
Tucson
California
California Center for Clinical Research
Arcadia
Hope Clinical Research
Canoga Park
United Clinical Research
Huntington Park
Medical Center for Clinical Research - Wake Research
San Diego
Optimus Medical Group, Inc.
San Francisco
Colorado
AFC Urgent Care Denver
Denver
Connecticut
Planned Parenthood of Southern New England
New Haven
Florida
Precision Clinical Research
Lauderdale Lakes
South Florida Research Center, Inc.
Miami
Global Health Research Center
Miami Lakes
Panax Clinical Research
Miami Lakes
Physician Care Clinical Research LLC
Sarasota
Comprehensive Clinical Trials, LLC
West Palm Beach
Georgia
Columbus Regional Research Institute - IACT Health
Columbus
Renew Health Clinical Research, LLC
Lawrenceville
Meridian Clinical Research
Richmond Hill
Idaho
ASR, LLC
Nampa
Illinois
John H. Stroger Jr. Hospital of Cook County
Chicago
Louisiana
DM Clinical Research
Alexandria
DelRicht Research
New Orleans
Michigan
Valley OB-GYN
Saginaw
Mississippi
MedPharmics, LLD
Biloxi
University of MS Medical Center
Jackson
North Carolina
Wake Research Associates, LLC
Raleigh
PMG Research of Salisbury
Salisbury
PMG Research, Inc. - Wilmington Health
Wilmington
New Mexico
Bosque Women's Care
Albuquerque
Nevada
Nevada Obstetrical Charity Clinic
Las Vegas
Ohio
University of Cincinnati Physicians
Cincinnati
Pennsylvania
Planned Parenthood Southeastern Pennsylvania
Philadelphia
Magee Womens Hospital of UPMC
Pittsburgh
South Carolina
Invocare Clinical Research Center
West Columbia
Tennessee
University of Tennessee Medical Center
Knoxville
Adams Patterson OB/GYN, Medical Research Center of Memphis
Memphis
Texas
Premier Family Physicians
Austin
Gadolin Research
Beaumont
CityDoc Urgent Care
Dallas
Centex Studios, Inc.
Houston
Discovery MM Services, Inc.
Houston
Research Network America
Houston
S.E.Tx. Family Planning and Cancer Screening (SOGA)
Houston
Texas Center for Drug Development, Inc.
Houston
North Texas Family Medicine
Plano
Neere Bhatia, MD OB/GYN
San Antonio
Virginia
The Group for Women
Norfolk
Time Frame
Start Date: 2017-11-03
Completion Date: 2019-08-22
Participants
Target number of participants: 860
Treatments
Active_comparator: 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.
Placebo_comparator: 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.
Sponsors
Collaborators: Clinical Research Management, Inc.
Leads: Evofem Inc.

This content was sourced from clinicaltrials.gov