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Phase 2B/3 Double-blinded Placebo-controlled

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ClinicalTrials.gov Identifier: NCT03107377
Recruitment Status : Completed
First Posted : April 11, 2017
Results First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
Clinical Research Management, Inc.
Information provided by (Responsible Party):
Evofem Inc.

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

Condition or disease Intervention/treatment Phase
Chlamydia Trachomatis Infection Drug: EVO100 Drug: Placebo Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 860 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 2B double-blind placebo-controlled efficacy trial of EVO100 for the prevention of acquisition of urogenital Chlamydia trachomatis infection
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind placebo-controlled efficacy trial of EVO100
Primary Purpose: Prevention
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
Actual Study Start Date : November 3, 2017
Actual Primary Completion Date : August 22, 2019
Actual Study Completion Date : August 22, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Urogenital CT Infection [ Time Frame: 16 weeks ]
    Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT).


Secondary Outcome Measures :
  1. Urogenital GC Infection [ Time Frame: 16 weeks ]
    Proportion of subjects who experience urogenital GC infection during the study intervention period (incident infection of GC).


Other Outcome Measures:
  1. Compliance With EVO100 and Sensitivity Analyses (Part I) [ Time Frame: 16 weeks ]
    Summary of Coital Events during treatment

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Compliance With EVO100 and Sensitivity Analyses (Part II) [ Time Frame: 16 weeks ]
    Summary of number of applicators used via eDiary

  7. Compliance With EVO100 and Sensitivity Analyses (Part III) [ Time Frame: 16 weeks ]
    Study product adherence



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   844 female subjects, ages 18-45.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107377


Locations
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Sponsors and Collaborators
Evofem Inc.
Clinical Research Management, Inc.
Investigators
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Study Director: Kelly Culwell, MD Evofem Inc.
  Study Documents (Full-Text)

Documents provided by Evofem Inc.:
Study Protocol  [PDF] January 25, 2019
Statistical Analysis Plan  [PDF] September 24, 2019

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Responsible Party: Evofem Inc.
ClinicalTrials.gov Identifier: NCT03107377    
Other Study ID Numbers: EVO-003
First Posted: April 11, 2017    Key Record Dates
Results First Posted: August 12, 2020
Last Update Posted: August 12, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases