Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
105 participants
INTERVENTIONAL
2016-08-24
2016-12-12
Brief Summary
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Detailed Description
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At least 15 women in each group were of either African American or Hispanic ethnicity. Routine screening tests were performed on admission; and subjects assessed for BV via vaginal swabs obtained for grading by Amsel criteria.
A direct vaginal pH reading by research staff- was obtained before the speculum exam, as well as one hour, and six hours post-treatment (Day 0). At the one hour and six hour post treatment time points, the direct vaginal pH readings were taken on specimens collected from two different positions in the vagina, in case of incomplete distribution of the IP soon after administration. Both readings are included as data points. At the six hour timepoint, subjects were trained on self-collecting vaginal swabs and performing the vaginal pH test. At 12 hours post-treatment, subjects performed the vaginal pH test themselves using self-obtained swabs, and record their results for clinician review.
Subjects stayed overnight in the domiciliary unit, and vaginal pH and Amsel criteria was measured again by research staff at 24 (+/- 2) hours post-treatment before discharge on Day 1. The subjects were discharged with the appropriate pH testing supplies and diary. All women agreed to abstain from sexual intercourse, douching and use of any intravaginally applied products or devices until after their final study visit on Day 7.
Subjects measured their vaginal pH at 24 (+/-2) hour intervals for 5 days (Days 2-6) as outpatients and recorded the pH test results, and any change in vaginal comfort, in a provided diary. Subjects also recorded any activities engaged in from the abstinence criteria in the study exclusion list, if applicable, each day. On Day 7, subjects returned to the clinic with their diaries, had their vaginal pH and Amsel criteria determined by the clinic staff, and queried as to any vaginal discomfort (vaginal comfort assessment) over the course of the study, as self-recorded in their diaries.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Acidform Gel, Group A
Administration of a single vaginal dose of Acidform gel (5 g)
Acidform 5 g
Effect of 5 g vaginally administered Acidform on pH over 7 days
Acidform Gel, Group B
Administration of a single vaginal dose of Acidform gel (4 g)
Acidform 4 g
Effect of 4 g vaginally administered Acidform on pH over 7 days
Acidform Gel, Group C
Administration of a single vaginal dose of Acidform gel (3 g)
Acidform 3 g
Effect of 3 g vaginally administered Acidform on pH over 7 days
Placebo Gel, Group D
Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g)
Placebo 4 g
Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days
No intervention, Group E
No vaginal product administered
No interventions assigned to this group
Interventions
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Acidform 5 g
Effect of 5 g vaginally administered Acidform on pH over 7 days
Placebo 4 g
Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days
Acidform 4 g
Effect of 4 g vaginally administered Acidform on pH over 7 days
Acidform 3 g
Effect of 3 g vaginally administered Acidform on pH over 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. Able and willing to comply with all study procedures
7. Have not engaged in sexual intercourse, douching or used of any form of vaginal suppository or intravaginal device for 24 hours prior to enrollment.
8. Agree to abstain from sexual intercourse, douching or any form of vaginal suppository or intravaginal device use during course of study
9. Report menstrual cycle regularity (25- to 35- day menstrual cycles)
Exclusion Criteria
2. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study protocol
3. Any other medical condition(s) that, in the judgment of the investigator, might interfere with the study or require treatment that might interfere with the study
4. Family member of the investigation study staff
5. Pregnant or breast-feeding
6. Inability to provide informed consent
7. A subject with a history or expectation of noncompliance with medications or treatment protocol
8. Women with symptoms of Urinary Tract Infection (UTI) or Sexually Transmitted Infection (STI) reported or observed during examination, at screening\*.
9. Women who regularly use douches, vaginal medications or suppositories, feminine sprays, genital wipes or contraceptive spermicides, or report abnormal vaginal discharge in the past 48 hours prior to screening
10. Women who are menstruating or who would expect to menstruate during the study
11. Women who are currently using contraceptives that are directly delivered to the vaginal mucosa, such as NuvaRing
12. Any specific condition that, in the judgment of the Investigator, precludes participation because it could affect subject safety
18 Years
45 Years
FEMALE
Yes
Sponsors
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Clinical Research Management, Inc.
INDUSTRY
Johns Hopkins University
OTHER
MetroHealth Medical Center
OTHER
Evofem Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ann Avery, MD
Role: PRINCIPAL_INVESTIGATOR
Metro Health Medical Center
Seema Nayak, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
John M Griffiss, MD
Role: STUDY_DIRECTOR
Clinical Research Management, Inc.
Locations
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Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Metro Health Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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EVO-002
Identifier Type: -
Identifier Source: org_study_id