Chlamydia Trachomatis Infection Clinical Trial
Official title:
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
Verified date | July 2020 |
Source | Evofem Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 |
Enrollment | 860 |
Est. completion date | August 22, 2019 |
Est. primary completion date | August 22, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: 1. Healthy female subjects between 18 and 45 years, inclusive 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: 1. Participation in any study with an investigational compound or device within 30 days prior to signing informed consent 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 |
Country | Name | City | State |
---|---|---|---|
United States | Bosque Women's Care | Albuquerque | New Mexico |
United States | DM Clinical Research | Alexandria | Louisiana |
United States | California Center for Clinical Research | Arcadia | California |
United States | Premier Family Physicians | Austin | Texas |
United States | Gadolin Research | Beaumont | Texas |
United States | MedPharmics, LLD | Biloxi | Mississippi |
United States | Hope Clinical Research | Canoga Park | California |
United States | John H. Stroger Jr. Hospital of Cook County | Chicago | Illinois |
United States | University of Cincinnati Physicians | Cincinnati | Ohio |
United States | Columbus Regional Research Institute - IACT Health | Columbus | Georgia |
United States | CityDoc Urgent Care | Dallas | Texas |
United States | AFC Urgent Care Denver | Denver | Colorado |
United States | Centex Studios, Inc. | Houston | Texas |
United States | Discovery MM Services, Inc. | Houston | Texas |
United States | Research Network America | 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 | United Clinical Research | Huntington Park | California |
United States | University of MS Medical Center | Jackson | Mississippi |
United States | University of Tennessee Medical Center | Knoxville | Tennessee |
United States | Nevada Obstetrical Charity Clinic | Las Vegas | Nevada |
United States | Precision Clinical Research | Lauderdale Lakes | Florida |
United States | Renew Health Clinical Research, LLC | Lawrenceville | Georgia |
United States | Adams Patterson OB/GYN, Medical Research Center of Memphis | Memphis | Tennessee |
United States | South Florida Research Center, Inc. | Miami | Florida |
United States | Global Health Research Center | Miami Lakes | Florida |
United States | Panax Clinical Research | Miami Lakes | Florida |
United States | Coastal Clinical Research, Inc. | Mobile | Alabama |
United States | Mobile OB-GYN, PC | Mobile | Alabama |
United States | ASR, LLC | Nampa | Idaho |
United States | Planned Parenthood of Southern New England | New Haven | Connecticut |
United States | DelRicht Research | New Orleans | Louisiana |
United States | The Group for Women | Norfolk | Virginia |
United States | Planned Parenthood Southeastern Pennsylvania | Philadelphia | Pennsylvania |
United States | MedPharmics, LLC | Phoenix | Arizona |
United States | Precision Trials AZ, LLC | Phoenix | Arizona |
United States | Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania |
United States | North Texas Family Medicine | Plano | Texas |
United States | Wake Research Associates, LLC | Raleigh | North Carolina |
United States | Meridian Clinical Research | Richmond Hill | Georgia |
United States | Valley OB-GYN | Saginaw | Michigan |
United States | PMG Research of Salisbury | Salisbury | North Carolina |
United States | Neere Bhatia, MD OB/GYN | San Antonio | Texas |
United States | Medical Center for Clinical Research - Wake Research | San Diego | California |
United States | Optimus Medical Group, Inc. | San Francisco | California |
United States | Physician Care Clinical Research LLC | Sarasota | Florida |
United States | Eclipse Clinical Research | Tucson | Arizona |
United States | Invocare Clinical Research Center | West Columbia | South Carolina |
United States | Comprehensive Clinical Trials, LLC | West Palm Beach | Florida |
United States | PMG Research, Inc. - Wilmington Health | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Evofem Inc. | Clinical Research Management, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Compliance With EVO100 and Sensitivity Analyses (Part I) | Summary of Coital Events during treatment | 16 weeks | |
Other | 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. | 16 weeks | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | Compliance With EVO100 and Sensitivity Analyses (Part II) | Summary of number of applicators used via eDiary | 16 weeks | |
Other | Compliance With EVO100 and Sensitivity Analyses (Part III) | Study product adherence | 16 weeks | |
Primary | Urogenital CT Infection | Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT). | 16 weeks | |
Secondary | Urogenital GC Infection | Proportion of subjects who experience urogenital GC infection during the study intervention period (incident infection of GC). | 16 weeks |
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