Clinical trial NCT03107377: Phase 2B/3 Double-blinded Placebo-controlled
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chlamydia Trachomatis Infection
Lead sponsor: Evofem Inc.
Sponsor class: INDUSTRY
Collaborators: name: Clinical Research Management, Inc.
First posted: 2017-04-11
Enrollment: 860
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 2B double-blind placebo-controlled efficacy trial of EVO100 for the prevention of acquisition of urogenital Chlamydia trachomatis infection
Primary purpose: PREVENTION

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

Detailed description: Primary: To determine if intravaginal EVO100 reduces the risk of urogenital Chlamydia trachomatis (CT) infection.

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

Eligibility criteria: 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

Primary outcomes:
measure: Urogenital CT Infection
timeFrame: 16 weeks
Secondary outcomes:
measure: Urogenital GC Infection
timeFrame: 16 weeks
Other outcomes:
measure: Compliance With EVO100 and Sensitivity Analyses (Part I)
timeFrame: 16 weeks
measure: Subject Satisfaction With Product
timeFrame: 16 weeks
measure: Sexual Satisfaction
timeFrame: 16 weeks
measure: Compliance With EVO100 and Sensitivity Analyses
timeFrame: 16 weeks
measure: Compliance With EVO100 and Sensitivity Analyses
timeFrame: 16 weeks
measure: Compliance With EVO100 and Sensitivity Analyses (Part II)
timeFrame: 16 weeks
measure: Compliance With EVO100 and Sensitivity Analyses (Part III)
timeFrame: 16 weeks
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Mobile
country: United States
facility: Mobile OB-GYN, PC
state: Alabama
city: Phoenix
country: United States
facility: MedPharmics, LLC
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials AZ, LLC
state: Arizona
city: Tucson
country: United States
facility: Eclipse Clinical Research
state: Arizona
city: Arcadia
country: United States
facility: California Center for Clinical Research
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Huntington Park
country: United States
facility: United Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research - Wake Research
state: California
city: San Francisco
country: United States
facility: Optimus Medical Group, Inc.
state: California
city: Denver
country: United States
facility: AFC Urgent Care Denver
state: Colorado
city: New Haven
country: United States
facility: Planned Parenthood of Southern New England
state: Connecticut
city: Lauderdale Lakes
country: United States
facility: Precision Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: Global Health Research Center
state: Florida
city: Miami
country: United States
facility: South Florida Research Center, Inc.
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research LLC
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute - IACT Health
state: Georgia
city: Lawrenceville
country: United States
facility: Renew Health Clinical Research, LLC
state: Georgia
city: Richmond Hill
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Nampa
country: United States
facility: ASR, LLC
state: Idaho
city: Chicago
country: United States
facility: John H. Stroger Jr. Hospital of Cook County
state: Illinois
city: Alexandria
country: United States
facility: DM Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Saginaw
country: United States
facility: Valley OB-GYN
state: Michigan
city: Biloxi
country: United States
facility: MedPharmics, LLD
state: Mississippi
city: Jackson
country: United States
facility: University of MS Medical Center
state: Mississippi
city: Las Vegas
country: United States
facility: Nevada Obstetrical Charity Clinic
state: Nevada
city: Albuquerque
country: United States
facility: Bosque Women's Care
state: New Mexico
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research, Inc. - Wilmington Health
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians
state: Ohio
city: Philadelphia
country: United States
facility: Planned Parenthood Southeastern Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Womens Hospital of UPMC
state: Pennsylvania
city: West Columbia
country: United States
facility: Invocare Clinical Research Center
state: South Carolina
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Adams Patterson OB/GYN, Medical Research Center of Memphis
state: Tennessee
city: Austin
country: United States
facility: Premier Family Physicians
state: Texas
city: Beaumont
country: United States
facility: Gadolin Research
state: Texas
city: Dallas
country: United States
facility: CityDoc Urgent Care
state: Texas
city: Houston
country: United States
facility: Research Network America
state: Texas
city: Houston
country: United States
facility: Centex Studios, Inc.
state: Texas
city: Houston
country: United States
facility: Discovery MM Services, Inc.
state: Texas
city: Houston
country: United States
facility: S.E.Tx. Family Planning and Cancer Screening (SOGA)
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Plano
country: United States
facility: North Texas Family Medicine
state: Texas
city: San Antonio
country: United States
facility: Neere Bhatia, MD OB/GYN
state: Texas
city: Norfolk
country: United States
facility: The Group for Women
state: Virginia
Study officials:
affiliation: Evofem Inc.
name: Kelly Culwell, MD
role: STUDY_DIRECTOR
References:
citation: 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.