Phase 2B/3 Double-blinded Placebo-controlled

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Chlamydia Trachomatis Infection

In brief

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

Key facts

Study ID

NCT03107377

Run by

Evofem Inc.

People needed

860

Starts

2017-11-03

Expected to finish

2019-08-22

Last updated by the study team

2020-08-12

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.