HealthyPhase 1NCT02693418
Duration of Effect of Acidform Gel on Vaginal pH
A Phase 1 study testing Acidform 5 g, Acidform 4 g and Acidform 3 g in people with Healthy, run by Evofem Inc. at 2 sites in United States.
Trial summary
The objective of this study was 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Acidform 5 g, Acidform 4 g and Acidform 3 g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Aug 2016to 12 Dec 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects between 18 and 45 years, inclusive
- Ability to understand the consent process and procedures
- Subjects agree to be available for all study visits
- Written informed consent in accordance with institutional guidelines
- Negative pregnancy test
- Able and willing to comply with all study procedures
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- Have not engaged in sexual intercourse, douching or used of any form of vaginal suppository or intravaginal device for 24 hours prior to enrollment.
- Agree to abstain from sexual intercourse, douching or any form of vaginal suppository or intravaginal device use during course of study
- Report menstrual cycle regularity (25- to 35- day menstrual cycles)
Who cannot join
- Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study protocol
- 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
- Family member of the investigation study staff
- Pregnant or breast-feeding
- Inability to provide informed consent
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- A subject with a history or expectation of noncompliance with medications or treatment protocol
- Women with symptoms of Urinary Tract Infection (UTI) or Sexually Transmitted Infection (STI) reported or observed during examination, at screening*.
- 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
- Women who are menstruating or who would expect to menstruate during the study
- Women who are currently using contraceptives that are directly delivered to the vaginal mucosa, such as NuvaRing
- Any specific condition that, in the judgment of the Investigator, precludes participation because it could affect subject safety
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Metro Health Medical Center
Cleveland, Ohio, 44109
About this study
Official title: A Randomized, Placebo Controlled Pilot Study to Determine the Effect and Duration of Acidform Gel on Vaginal pH
The objective of this study was 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 was measured 1 h, 6 h, 12 h, 24 h, then once daily for 7 days. In addition, the participants were 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).
Read the detailed description
One hundred healthy volunteer women, 20 per each treatment arm, were treated with either Intravaginal Acidform Gel(IVAG), 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 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
- Healthy
- Being tested
- Acidform 5 g, Placebo 4 g, Acidform 4 g, Acidform 3 g
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acidform 5 gDrug
Effect of 5 g vaginally administered Acidform on pH over 7 days
Placebo 4 gDrug
Also called Natrasol 250 HX Pharm
Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days
Acidform 4 gDrug
Effect of 4 g vaginally administered Acidform on pH over 7 days
Acidform 3 gDrug
Effect of 3 g vaginally administered Acidform on pH over 7 days
| Study group | Role | What they receive |
|---|---|---|
| Acidform Gel, Group A | Experimental | Administration of a single vaginal dose of Acidform gel (5 g) Receives: Drug: Acidform 5 g |
| Acidform Gel, Group B | Experimental | Administration of a single vaginal dose of Acidform gel (4 g) Receives: Drug: Acidform 4 g |
| Acidform Gel, Group C | Experimental | Administration of a single vaginal dose of Acidform gel (3 g) Receives: Drug: Acidform 3 g |
| Placebo Gel, Group D | Placebo comparator | Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g) Receives: Drug: Placebo 4 g |
| No intervention, Group E | No intervention | No vaginal product administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention.
Vaginal swabs were used to collect samples from the vagina of women dosed with Acidform, HEC placebo, or no treatment. The pH of the samples was measured at pre-determined time points over the course of 7 days.
Measured: Baseline (Day 0), 1, 6 & 12 hours post treatment, and Days 1, 2, 3, 4, 5, 6 & 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study start24 Aug 2016
- Primary completion12 Dec 2016
- Study completion12 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evofem Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Management, Inc., Johns Hopkins University, MetroHealth Medical Center
- Responsible party
- Sponsor
- Investigators
- Ann Avery, MD, Principal investigator, Metro Health Medical CenterSeema Nayak, MD, Principal investigator, Johns Hopkins UniversityJohn M Griffiss, MD, Study director, Clinical Research Management, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693418
- Sponsor's protocol ID
- EVO-002
- Status last verified
- Oct 2020
- First submitted
- 18 Feb 2016
- Last updated
- 20 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled Pilot Study to Determine the Effect and Duration of Acidform Gel on Vaginal pH
- ClinicalTrials.gov ID
- NCT02693418
- Acronym / sponsor ID
- EVO-002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Evofem Inc.Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Management, Inc., Johns Hopkins University, MetroHealth Medical Center
- Study start
- 24 Aug 2016 (actual)
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 12 Dec 2016 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Posted 20 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was 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 was measured 1 h, 6 h, 12 h, 24 h, then once daily for 7 days. In addition, the participants were 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, were treated with either Intravaginal Acidform Gel(IVAG), 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Acidform Gel, Group A | Experimental | Drug: Acidform 5 gAdministration of a single vaginal dose of Acidform gel (5 g) |
| Acidform Gel, Group B | Experimental | Drug: Acidform 4 gAdministration of a single vaginal dose of Acidform gel (4 g) |
| Acidform Gel, Group C | Experimental | Drug: Acidform 3 gAdministration of a single vaginal dose of Acidform gel (3 g) |
| Placebo Gel, Group D | Placebo comparator | Drug: Placebo 4 gAdministration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g) |
| No intervention, Group E | No intervention | –No vaginal product administered |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy female subjects between 18 and 45 years, inclusive
- Ability to understand the consent process and procedures
- Subjects agree to be available for all study visits
- Written informed consent in accordance with institutional guidelines
- Negative pregnancy test
Key exclusion criteria (12 listed)
- Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study protocol
- 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
- Family member of the investigation study staff
- Pregnant or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acidform 5 gEffect of 5 g vaginally administered Acidform on pH over 7 days | Drug | Acidform Gel, Group A |
| Placebo 4 gAlso: Natrasol 250 HX PharmEffect of 4 g of vaginally administered HEC placebo gel on pH over 7 days | Drug | Placebo Gel, Group D |
| Acidform 4 gEffect of 4 g vaginally administered Acidform on pH over 7 days | Drug | Acidform Gel, Group B |
| Acidform 3 gEffect of 3 g vaginally administered Acidform on pH over 7 days | Drug | Acidform Gel, Group C |
Primary outcome
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention.
Time frame: Baseline (Day 0), 1, 6 & 12 hours post treatment, and Days 1, 2, 3, 4, 5, 6 & 7.
Vaginal swabs were used to collect samples from the vagina of women dosed with Acidform, HEC placebo, or no treatment. The pH of the samples was measured at pre-determined time points over the course of 7 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Avery, MD principal investigator
Metro Health Medical Center
Seema Nayak, MD principal investigator
Johns Hopkins University
John M Griffiss, MD study director
Clinical Research Management, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acidform 5 g, Acidform 4 g and Acidform 3 g in people with Healthy, run by Evofem Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. (time frame: Baseline (Day 0), 1, 6 & 12 hours post treatment, and Days 1, 2, 3, 4, 5, 6 & 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.