Phase 2B/3 Double-blinded Placebo-controlled

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107377
• Other study ID #: EVO-003
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 3, 2017
• Est. completion date: August 22, 2019

Study information

• Verified date: July 2020
• Source: Evofem Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• 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

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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

Related Conditions & MeSH terms

• Chlamydia Infections
• Chlamydia Trachomatis Infection
• Infection

Intervention

Drug:
• EVO100
5 g dose applied up to 1 hour prior to coitus
• Placebo
5 g dose applied up to 1 hour prior to coitus

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Evofem Inc.	Clinical Research Management, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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