Duration of Effect of Acidform Gel on Vaginal pH

NCT02693418 | Completed Phase 1 Results

• 1 other identifier: EVO-002
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief 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. 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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 0), 1, 6 & 12 hours post treatment, and Days 1, 2, 3, 4, 5, 6 & 7.

Other Outcomes (1)

• The Effect of a Single Dose of Acidform Gel (3, 4 or 5 g), Placebo Gel (4 g), or no Treatment on Asymptomatic Bacterial Vaginosis (BV) Based on Amsel Criteria.

  Baseline (Day 0), Day 1 and Day 7

Study Arms (5)

Acidform Gel, Group A

EXPERIMENTAL

Administration of a single vaginal dose of Acidform gel (5 g)

Drug: Acidform 5 g

Acidform Gel, Group B

EXPERIMENTAL

Administration of a single vaginal dose of Acidform gel (4 g)

Drug: Acidform 4 g

Acidform Gel, Group C

EXPERIMENTAL

Administration of a single vaginal dose of Acidform gel (3 g)

Drug: Acidform 3 g

Placebo Gel, Group D

PLACEBO COMPARATOR

Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g)

Drug: Placebo 4 g

No intervention, Group E

NO INTERVENTION

No vaginal product administered

Interventions

Acidform 5 g DRUG

Effect of 5 g vaginally administered Acidform on pH over 7 days

Acidform Gel, Group A

Placebo 4 g DRUG

Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days

Also known as: Natrasol 250 HX Pharm

Placebo Gel, Group D

Acidform 4 g DRUG

Effect of 4 g vaginally administered Acidform on pH over 7 days

Acidform Gel, Group B

Acidform 3 g DRUG

Effect of 3 g vaginally administered Acidform on pH over 7 days

Acidform Gel, Group C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Evofem Inc.: lead
• Clinical Research Management, Inc.: collaborator
• Johns Hopkins University: collaborator
• MetroHealth Medical Center: collaborator

Study Sites (2)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Metro Health Medical Center

Cleveland, Ohio, 44109, United States

Location

Limitations and Caveats

Low number of subjects at each time point and lost specimens meant a complete analyses were not conducted on specimens from all subjects at all time points and further studies are required to confirm these findings.

Results Point of Contact

• Title: Kelly Culwell, MD, MPH, FACOG
• Organization: Evofem Biosciences

kculwell@evofem.com

858-550-1900

Study Officials

• Ann Avery, MD

  Metro Health Medical Center

  PRINCIPAL INVESTIGATOR

• Seema Nayak, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• John M Griffiss, MD

  Clinical Research Management, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 26, 2016
• Study Start: August 24, 2016
• Primary Completion: December 12, 2016
• Study Completion: December 12, 2016
• Last Updated: November 20, 2020
• Results First Posted: November 20, 2020

Record last verified: 2020-10

Locations

US (2)