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Duration of Effect of Acidform Gel on Vaginal pH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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).

Condition or disease Intervention/treatment Phase
Healthy Drug: Acidform 5 g Drug: Placebo 4 g Drug: Acidform 4 g Drug: Acidform 3 g Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Placebo Controlled Pilot Study to Determine the Effect and Duration of Acidform Gel on Vaginal pH
Actual Study Start Date : August 24, 2016
Actual Primary Completion Date : December 12, 2016
Actual Study Completion Date : December 12, 2016

Arm Intervention/treatment
Experimental: Acidform Gel, Group A
Administration of a single vaginal dose of Acidform gel (5 g)
Drug: Acidform 5 g
Effect of 5 g vaginally administered Acidform on pH over 7 days

Experimental: Acidform Gel, Group B
Administration of a single vaginal dose of Acidform gel (4 g)
Drug: Acidform 4 g
Effect of 4 g vaginally administered Acidform on pH over 7 days

Experimental: Acidform Gel, Group C
Administration of a single vaginal dose of Acidform gel (3 g)
Drug: Acidform 3 g
Effect of 3 g vaginally administered Acidform on pH over 7 days

Placebo Comparator: Placebo Gel, Group D
Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g)
Drug: Placebo 4 g
Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days

No Intervention: No intervention, Group E
No vaginal product administered



Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
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. 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

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): NCT02693418


Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, Ohio
Metro Health Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Evofem Inc.
Clinical Research Management, Inc.
Johns Hopkins University
MetroHealth Medical Center
Investigators
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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.

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Responsible Party: Evofem Inc.
ClinicalTrials.gov Identifier: NCT02693418    
Other Study ID Numbers: EVO-002
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided