Phase 2B/3 Double-blinded Placebo-controlled



Status:Recruiting
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 45
Updated:9/30/2018
Start Date:November 3, 2017
End Date:May 2019
Contact:Brandi Howard
Email:bhoward@evofem.com
Phone:201-783-6749

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Phase 2B/3 Double-blinded Placebo-controlled Efficacy Trial of Amphora® Gel for the Prevention of Acquisition of Urogenital Chlamydia Trachomatis Infection

Phase 2B double-blind placebo-controlled efficacy trial of Amphora® gel for the prevention of
acquisition of urogenital Chlamydia trachomatis infection

Primary: To determine if intravaginal Amphora gel reduces the risk of urogenital Chlamydia
trachomatis (CT) infection.

Secondary: To determine if intravaginal Amphora gel reduces the risk of urogenital Neisseria
gonorrhoeae (GC) infection.

Exploratory:To determine if Amphora gel use rate (subject adherence to instructed use) has an
effect on proportion of subjects who experience at least one CT or GC infection during the
study intervention period.

Primary Outcome Measures: Proportion of subjects who experience at least one urogenital CT
infection during the study intervention period (incident infection of CT).

Secondary Outcome Measures: Proportion of subjects who experience at least one urogenital GC
infection during the study intervention period (incident infection of GC).

Exploratory Outcome Measures:

- Compliance with Amphora gel 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

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
We found this trial at
52
sites
West Palm Beach, Florida 33409
Principal Investigator: Ronald Ackerman, MD
Phone: 561-478-3177
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Albuquerque, New Mexico 87109
Principal Investigator: Carrie Swartz, MD
Phone: 505-218-0976
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Alexandria, Louisiana 71301
Principal Investigator: Naseem Jaffrani, MD
Phone: 281-517-0550
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207 South Santa Anita Street
Arcadia, California 91007
Principal Investigator: Roberto Valenton, MD
Phone: 626-284-8401
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750 Hammond Drive Northeast
Atlanta, Georgia 30342
Principal Investigator: Vasundhara Cheekati, MD
Phone: 404-400-2255
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Austin, Texas 78735
Principal Investigator: Rita Schultz, MD
Phone: 972-354-1520
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Beaumont, Texas 77701
Principal Investigator: Marquita Anderson, MD
Phone: 713-581-9994
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Biloxi, Mississippi 39531
Principal Investigator: Paul Matherne, MD
Phone: 228-206-1283
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Canoga Park, California 91303
Principal Investigator: Hessam Aazami, MD
Phone: 818-999-4673
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
Principal Investigator: Ashlesha Patel, MD
Phone: 312-864-6659
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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Cincinnati, Ohio 45219
Principal Investigator: Michael Thomas, MD
Phone: 513-584-4509
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Columbus, Georgia 31901
Principal Investigator: Jeff Kingsley, MD
Phone: 706-321-0495
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5301 West Lovers Lane
Dallas, Texas 75209
Principal Investigator: Rai Shiwali, MD
Phone: 214-871-7000
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Denver, Colorado 80202
Principal Investigator: Johnny Shen, MD
Phone: 303-692-8000
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900 West 49th Street
Hialeah, Florida 33012
Principal Investigator: Dario Altamirano, MD
Phone: 305-819-1559
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Houston, Texas 77021
Principal Investigator: Jacqueline Brown, MD
Phone: 800-674-3624
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Houston, Texas 77058
Principal Investigator: Bassem Maximos, MD
Phone: 281-282-0808
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Houston, Texas 77061
Principal Investigator: Caroline Mbogua, MD
Phone: 832-532-4210
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Houston, Texas 77074
Principal Investigator: Harold Daily, MD
Phone: 703-774-6550
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Houston, Texas
Principal Investigator: Teresa Becker, MD
Phone: 713-838-2022
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Huntington Park, California 90255
Principal Investigator: Peyman Banooni, MD
Phone: 310-252-6300
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Jackson, Mississippi 39216
Principal Investigator: Leandro Mena, MD
Phone: 601-815-5861
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Knoxville, Tennessee 37920
Principal Investigator: Nikki Zite, MD
Phone: 865-308-9773
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Las Vegas, Nevada 89106
Principal Investigator: Kord Strebel, MD
Phone: 702-438-2229
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4700 North State Road 7
Lauderdale Lakes, Florida 33319
Principal Investigator: Linda Green, MD
Phone: 954-915-9991
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Lawrenceville, Georgia 30046
Principal Investigator: Daniel Daughtery, MD
Phone: 706-223-3560
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Memphis, Tennessee 38120
Principal Investigator: Benjamin Chappell, MD
Phone: 901-767-3810
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286 Westward Drive
Miami, Florida 33135
Principal Investigator: Omar Benitez, MD
Phone: 305-456-3236
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Miami Lakes, Florida 33014
Principal Investigator: Robert Perry, MD
Phone: 305-698-4500
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Miami Lakes, Florida 33016
Principal Investigator: Ramon Hechavarria, MD
Phone: 305-824-0026
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Mobile, Alabama 36608
Principal Investigator: Danilo Herrera, MD
Phone: 251-414-1984
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Mobile, Alabama 36608
Principal Investigator: Hope McLean, MD
Phone: 251-633-0793
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16111 North Brinson Street
Nampa, Idaho 83687
Principal Investigator: J'Cinda Bitters, MD
Phone: 208-906-1600
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New Haven, Connecticut 06511
Principal Investigator: Clair Kaplan
Phone: 203-752-2864
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New Orleans, Louisiana 70124
Principal Investigator: Patrick Dennis, MD
Phone: 504-336-2667
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Norfolk, Virginia 23502
Principal Investigator: Mehdi Parva, MD
Phone: 757-471-3375
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Philadelphia, Pennsylvania 19107
Principal Investigator: Joel Lebed, MD
Phone: 215-351-5543
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Phoenix, Arizona 85015
Principal Investigator: Charles Plimpton, MD
Phone: 602-368-1928
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Phoenix, Arizona 85032
Principal Investigator: Valerie Sorkin-Wells, MD
Phone: 602-931-4507
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300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Principal Investigator: Sharon Achilles, MD
Phone: 412-641-5496
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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Plano, Texas 75093
Principal Investigator: Heather Akins, MD
Phone: 972-354-1520
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Principal Investigator: Pouruchis Bhiwandiwalla, MD
Phone: 919-781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Richmond Hill, Georgia 31324
Principal Investigator: Richard Mazur, MD
Phone: 912-443-4253
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Saginaw, Michigan 48602
Principal Investigator: Jacquelyn Robinson, MD
Phone: 989-753-8453
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Salisbury, North Carolina 28144
Principal Investigator: Michael Mills, MD
Phone: 704-647-9913
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San Antonio, Texas 78212
Principal Investigator: Neere Bhatia, MD
Phone: 210-222-2694
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San Diego, California 92108
Principal Investigator: Dane Shipp, MD
Phone: 619-521-2835
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San Francisco, California 94102
Principal Investigator: Shawn Hassler, MD
Phone: 415-397-0700
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Sarasota, Florida 34321
Principal Investigator: Gregory Swor, MD
Phone: 941-954-2355
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Tucson, Arizona 85745
Principal Investigator: Vicki Kalen, MD
Phone: 520-647-9926
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West Columbia, South Carolina 29169
Principal Investigator: Ravenell Orson, MD
Phone: 803-764-2406
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1907 Tradd Court
Wilmington, North Carolina 28401
Principal Investigator: Sarah Gore, MD
Phone: 910-815-6108
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