Phase 2B/3 Double-blinded Placebo-controlled

July 27, 2020 updated by: Evofem Inc.

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

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 Overview

Status

Completed

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

860

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research, Inc.
      • Mobile, Alabama, United States, 36608
        • Mobile Ob-Gyn, PC
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • MedPharmics, LLC
      • Phoenix, Arizona, United States, 85032
        • Precision Trials AZ, LLC
      • Tucson, Arizona, United States, 85745
        • Eclipse Clinical Research
    • California
      • Arcadia, California, United States, 91007
        • California Center for Clinical Research
      • Canoga Park, California, United States, 91303
        • Hope Clinical Research
      • Huntington Park, California, United States, 90255
        • United Clinical Research
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research - Wake Research
      • San Francisco, California, United States, 94102
        • Optimus Medical Group, Inc.
    • Colorado
      • Denver, Colorado, United States, 80202
        • AFC Urgent Care Denver
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Planned Parenthood of Southern New England
    • Florida
      • Lauderdale Lakes, Florida, United States, 33319
        • Precision Clinical Research
      • Miami, Florida, United States, 33135
        • South Florida Research Center, Inc.
      • Miami Lakes, Florida, United States, 33014
        • Panax Clinical Research
      • Miami Lakes, Florida, United States, 33016
        • Global Health Research Center
      • Sarasota, Florida, United States, 34239
        • Physician Care Clinical Research LLC
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials, Llc
    • Georgia
      • Columbus, Georgia, United States, 31901
        • Columbus Regional Research Institute - IACT Health
      • Lawrenceville, Georgia, United States, 30046
        • Renew Health Clinical Research, LLC
      • Richmond Hill, Georgia, United States, 31324
        • Meridian Clinical Research
    • Idaho
      • Nampa, Idaho, United States, 83687
        • ASR, LLC
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H. Stroger Jr. Hospital of Cook County
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • DM Clinical Research
      • New Orleans, Louisiana, United States, 70124
        • DelRicht Research
    • Michigan
      • Saginaw, Michigan, United States, 48602
        • Valley OB-GYN
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
        • MedPharmics, LLD
      • Jackson, Mississippi, United States, 39213
        • University of MS Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Nevada Obstetrical Charity Clinic
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Bosque Women's Care
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Salisbury, North Carolina, United States, 28144
        • PMG Research of Salisbury
      • Wilmington, North Carolina, United States, 28401
        • PMG Research, Inc. - Wilmington Health
    • Ohio
      • Cincinnati, Ohio, United States, 41073
        • University of Cincinnati Physicians
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Planned Parenthood Southeastern Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-3180
        • Magee Womens Hospital of UPMC
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Invocare Clinical Research Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
      • Memphis, Tennessee, United States, 38120
        • Adams Patterson OB/GYN, Medical Research Center of Memphis
    • Texas
      • Austin, Texas, United States, 78735
        • Premier Family Physicians
      • Beaumont, Texas, United States, 77701
        • Gadolin Research
      • Dallas, Texas, United States, 75204
        • CityDoc Urgent Care
      • Houston, Texas, United States, 77081
        • Texas Center for Drug Development, Inc.
      • Houston, Texas, United States, 77021
        • Research Network America
      • Houston, Texas, United States, 77058
        • Centex Studios, Inc.
      • Houston, Texas, United States, 77061
        • Discovery MM Services, Inc.
      • Houston, Texas, United States, 77074
        • S.E.Tx. Family Planning and Cancer Screening (SOGA)
      • Plano, Texas, United States, 75093
        • North Texas Family Medicine
      • San Antonio, Texas, United States, 78212
        • Neere Bhatia, MD OB/GYN
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • The Group for Women

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
5 g dose applied up to 1 hour prior to coitus
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.
5 g dose applied up to 1 hour prior to coitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urogenital CT Infection
Time Frame: 16 weeks
Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT).
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urogenital GC Infection
Time Frame: 16 weeks
Proportion of subjects who experience urogenital GC infection during the study intervention period (incident infection of GC).
16 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance With EVO100 and Sensitivity Analyses (Part I)
Time Frame: 16 weeks
Summary of Coital Events during treatment
16 weeks
Subject Satisfaction With Product
Time Frame: 16 weeks
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
Sexual Satisfaction
Time Frame: 16 weeks
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
Compliance With EVO100 and Sensitivity Analyses
Time Frame: 16 weeks
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
Compliance With EVO100 and Sensitivity Analyses
Time Frame: 16 weeks
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
Compliance With EVO100 and Sensitivity Analyses (Part II)
Time Frame: 16 weeks
Summary of number of applicators used via eDiary
16 weeks
Compliance With EVO100 and Sensitivity Analyses (Part III)
Time Frame: 16 weeks
Study product adherence
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Kelly Culwell, MD, Evofem Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2017

Primary Completion (Actual)

August 22, 2019

Study Completion (Actual)

August 22, 2019

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

August 12, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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