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Duration of Effect of Acidform Gel on Vaginal pH

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ClinicalTrials.gov Identifier: NCT02693418
Recruitment Status : Completed
First Posted : February 26, 2016
Last Update Posted : November 21, 2019
Sponsor:
Collaborators:
Clinical Research Management, Inc.
Johns Hopkins University
MetroHealth Medical Center
Information provided by (Responsible Party):
Evofem Inc.

Tracking Information
First Submitted Date  ICMJE February 18, 2016
First Posted Date  ICMJE February 26, 2016
Last Update Posted Date November 21, 2019
Actual Study Start Date  ICMJE August 24, 2016
Actual Primary Completion Date December 12, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2016)
Vaginal pH following a single of Acidform (3, 4, and 5 g), HEC placebo (4 g), and no intervention [ Time Frame: 7 days ]
Vaginal swabs will be used to collect samples from the vagina of women dosed with Acidform, HEC placebo, or no treatment. The pH of the samples will be measured at pre-determined time points over the course of 7 days. pH data will be compared across interventions to determine an appropriate dose and dosing interval for a Phase 2 trial to determine the ability of Acidform to prevent recurrence of bacterial vaginosis.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 5, 2016)
The effect of Acidform gel (3, 4 or 5 g), placebo gel (4 g), or no treatment on asymptomatic bacterial vaginosis (BV): Changes in Amsel Criteria between interventions. [ Time Frame: Baseine and 7 days ]
Amsel Criteria will be used baseline and 7 days following the single dose. Changes in Amsel Criteria between interventions will be evaluated.
Original Other Pre-specified Outcome Measures
 (submitted: February 25, 2016)
The effect of Acidform gel (3, 4 or 5 g), placebo gel (4 g), or no treatment on asymptomatic bacterial vaginosis (BV): Changes in Amsel Criteria between interventions. [ Time Frame: 7 days ]
Amsel Criteria will be used prior to dosing and again after 7 days following the single dose. Changes in Amsel Criteria between interventions will be evaluated.
 
Descriptive Information
Brief Title  ICMJE Duration of Effect of Acidform Gel on Vaginal pH
Official Title  ICMJE A Randomized, Placebo Controlled Pilot Study to Determine the Effect and Duration of Acidform Gel on Vaginal pH
Brief Summary The objective of this study is to determine the magnitude and duration of the reduction in pH (acidification) following a single dose of Acidform vaginal gel containing 3, 4, or 5 g compared with hydroxyethylcellulose placebo gel (4 g) or no treatment. Vaginal pH will be measured 1 h, 6 h, 12 h, 24 h, then once daily for 7 days. In addition, the participants will be assessed for an exploratory endpoint to the determine effect of one dose of Acidform gel (3, 4 or 5 g) or placebo gel (4 g) or no treatment, on asymptomatic bacterial vaginosis (BV).
Detailed Description

One hundred healthy volunteer women, 20 per each treatment arm, will be treated with either IVAG Acidform gel, 5 g dose (GROUP A), Acidform gel, 4 g dose (GROUP B), Acidform gel, 3 g dose (GROUP C), Universal Placebo Gel (UPG), 4 g (GROUP D) or no treatment (GROUP E). For GROUPS A, B, C and D, treatment is defined as speculum exam plus instillation of Investigational Product (IP) or placebo gel. For GROUP E (control), no treatment is defined as speculum exam and no gel instillation.

At least 15 women in each group will be of either African American or Hispanic ethnicity. Routine screening tests will be performed on admission; and subjects will be assessed for BV via vaginal swabs obtained for grading by Amsel criteria.

A direct vaginal pH reading will be research staff-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 will be taken on specimens collected from two different positions in the vagina, in case of incomplete distribution of the IP soon after administration. Both readings will be included as data points. At the six hour timepoint, subjects will be trained on self-collecting vaginal swabs and performing the vaginal pH test. At 12 hours post-treatment, subjects will perform the vaginal pH test themselves using self-obtained swabs, and record their results for clinician review.

Subjects will stay overnight in the domiciliary unit, and vaginal pH and Amsel criteria will be measured again by research staff at 24 (+/- 2) hours post-treatment before discharge on Day 1. The subjects will be discharged with the appropriate pH testing supplies and diary. All women must agree 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 will measure their vaginal pH at 24 (+/-2) hour intervals for 5 days (Days 2-6) as outpatients and record the pH test results, and any change in vaginal comfort, in a provided diary. Subjects will also record any activities engaged in from the abstinence criteria in the study exclusion list, if applicable, each day. On Day 7, subjects will return to the clinic with their diaries, have 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Acidform 5 g
    Effect of 5 g vaginally administered Acidform on pH over 7 days
  • Drug: Placebo 4 g
    Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days
  • Drug: Acidform 4 g
    Effect of 4 g vaginally administered Acidform on pH over 7 days
  • Drug: Acidform 3 g
    Effect of 3 g vaginally administered Acidform on pH over 7 days
Study Arms  ICMJE
  • Experimental: Acidform Gel, Group A
    Administration of a single vaginal dose of Acidform gel (5 g)
    Intervention: Drug: Acidform 5 g
  • Experimental: Acidform Gel, Group B
    Administration of a single vaginal dose of Acidform gel (4 g)
    Intervention: Drug: Acidform 4 g
  • Experimental: Acidform Gel, Group C
    Administration of a single vaginal dose of Acidform gel (3 g)
    Intervention: Drug: Acidform 3 g
  • Placebo Comparator: Placebo Gel, Group D
    Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g)
    Intervention: Drug: Placebo 4 g
  • No Intervention: No intervention, Group E
    No vaginal product administered
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 12, 2016
Actual Primary Completion Date December 12, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. 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:

  1. Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
  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 UTI or 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02693418
Other Study ID Numbers  ICMJE EVO-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Evofem Inc.
Study Sponsor  ICMJE Evofem Inc.
Collaborators  ICMJE
  • Clinical Research Management, Inc.
  • Johns Hopkins University
  • MetroHealth Medical Center
Investigators  ICMJE
Principal Investigator: Ann Avery, MD Metro Health Medical Center
Principal Investigator: Seema Nayak, MD Johns Hopkins University
Study Director: John M Griffiss, MD Clinical Research Management, Inc.
PRS Account Evofem Inc.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP