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Clinical Trial to Survey Results of Restore Moisturizing Lubricant for Recurrent Bacterial Vaginosis

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ClinicalTrials.gov Identifier: NCT03734523
Recruitment Status : Not yet recruiting
First Posted : November 8, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Sexual Health and Wellness Institute

Brief Summary:

Background

Bacterial Vaginosis is the most common vaginal infection in women in their reproductive years and a difficult one to treat. In the United States, the National Health and Nutrition Examination Survey (NHANES), estimated the prevalence of BV was 29 percent in the general population of women aged 14 to 49 years and 50 percent in African-American women . It is characterized by a shift in vaginal flora from an acidic environment due to acid producing lactobacilli to a mixture of anerobic and facultative microorganisms. BV causes symptoms of vaginal odor, itching, discharge and irritation and can greatly impact a woman's health, quality of life, sexual relations and well-being. BV has also been associated with an increased risk of preterm labor, STD acquisition and vaginal cuff cellulitis after hysterectomy (5). After treatment with antibiotics, recurrences are common.

Normal vaginal flora is lactobacilli dominant. Lactobacilli maintain vaginal pH in the acidic range and keep the growth of BV associated bacteria at low levels. Lactobacilli also produce proteins with bacteriocidal activity which help to maintain their dominance. Anything that alters the vaginal flora and changes the pH to a more basic environment may increase the risk of BV.

Currently, there are many sexual lubricants and vaginal moisturizers available on the market. It has recently been shown that many of these are hyperosmolar and it is thought that hyperosmolar lubricants can be damaging to the epithelium and may alter the pH of the vagina. It is postulated that lubricants and moisturizers may predispose to BV by altering the pH of the vagina.

Restore, by Good Clean Love, is a moisturizing personal lubricant that has been on the market for 3 years. It is available without a prescription. It is formulated to bio-match the vaginal secretions of women with L. crispatus-dominated microbiota. Restore has a pH of 3.7 with racemic 1% lactic acid, and is iso-osmolar with serum. It is, therefore, much less likely to alter the acid base balance of the vagina, and therefore less likely to predispose to BV.

The aim of this study is to determine if Restore gel aids in reestablishing optimal acidic vaginal pH levels, therefore creating the environment for good lactobacilli to be reintroduced and thrive. The secondary aim is to determine if the continued use of Restore will prevent recurrence over a 10-week period.

This study is designed to be a pilot/feasibility study. The study will compare the subjects to a historical recurrence risk. It will also assess the ability of subjects to comply with the protocol.


Condition or disease Intervention/treatment
Bacterial Vaginosis Vaginal Flora Imbalance Drug: Metrogel Device: BV Diary

Detailed Description:

Methods:

Over a 2 year period, women in one academic OBGYN clinic with a history of at least one prior episode of BV in the past year, (confirmed via medical records) who currently have BV diagnosed via wet mount and vaginal pH and confirmed with the Nugent score, will be approached regarding their desire to participate in the trial. If the subject chooses to participate after a thorough discussion of the risks and benefits, she will sign the informed consent and be enrolled in the trial. Demographic information will be recorded via questionnaire (see attached). A total of 20 patients will be enrolled.

Once enrolled, each subject will receive a packet of study materials from their physician/clinician as well as a "Guide to Completing the BV Trial." This is a booklet containing detailed instructions for each day of the study as well as a diary in which participants will record daily symptoms.

Subjects will return at 1-week after starting the treatment. They will be screened for BV using the wet mount, vaginal pH and Nugent scoring. If a superinfection with yeast has occurred, they will be treated via standard of care treatments. If BV is confirmed at the one week visit, they will be treated with a 7 day course of metrogel (standard of care). If they are not diagnosed with BV, they will continue to use Restore every other day until the completion of the study. After 10 completed weeks, the subject will be rescreened for BV using the wet mount, vaginal pH and Nugent scoring.

Subjects be asked to swab of their vagina for vaginal secretions and make a slide for Nugent scoring. This will be done once weekly, right before inserting the next dose of Restore. They will be given hands on and written instructions on how to make the slide. They will give the slides to the study investigator at each visit and these will hand delivered to Dr. Deirdre Ohanlon at UMMC.

Subjects will return every 2 weeks for the remainder of the study to assess AE/SAE.

Monitoring of AE / SAE

The physician/clinician who referred the patient for participation in the study will monitor AEs and SAEs. Good Clean Love, Sponsor of the study, will not interact directly with participants but will have a staff member in the role of "Physician Liaison" available to assist physicians/clinicians at all times for the duration of the study. To maintain confidentiality, the Physician Liaison is the only Sponsor staff has access to patient information including patient names and patient physician names and contact information.

Study Oversight

The study may be prematurely terminated if it is determined that an abnormal number of participants experience SAEs directly associated with study materials, as verified and reported by their physician/clinician. Study Sponsor (Good Clean Love) will be responsible for making this determination.

Data Management

When all participants have completed the study with the participating clinicians, participants' diaries and results of swab tests will be collected from participating clinicians, and clinical experiences during the trial will be obtained by short telephone interviews by the study sponsor. Data from the participants' diaries and data obtained from phone interview will be analyzed.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Trial to Survey Results of Restore Moisturizing Lubricant for Recurrent Bacterial Vaginosis
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Group/Cohort Intervention/treatment
Pilot Group
Subjects will return at 1-week after starting the treatment. They will be screened for BV using the wet mount, vaginal pH and Nugent scoring. If a superinfection with yeast has occurred, they will be treated via standard of care treatments. If BV is confirmed at the one week visit, they will be treated with a 7 day course of metrogel (standard of care). If they are not diagnosed with BV, they will continue to use Restore every other day until the completion of the study. After 10 completed weeks, the subject will be rescreened for BV using the wet mount, vaginal pH and Nugent scoring.
Drug: Metrogel
If BV is confirmed in participants during the course of the study, they will be treated with a 7 day course of metrogel (standard of care.)

Device: BV Diary
Patients will record progress in a BV Diary to aid researchers in monitoring any signs or symptoms of a BV infection. This device will help determine appropriate next steps or treatment if necessary.




Primary Outcome Measures :
  1. Vaginal pH Levels [ Time Frame: 10 weeks ]
    The primary outcome measure is to determine if Restore gel aids in reestablishing optimal acidic vaginal pH levels, therefore creating the environment for good lactobacilli to be reintroduced and thrive.


Secondary Outcome Measures :
  1. BV Recurrence [ Time Frame: 10 weeks ]
    The secondary outcome measure is to determine if the continued use of Restore will prevent recurrence over a 10-week period.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population

Inclusion/Exclusion Criteria

Inclusion:

Women aged 18-55

Exclusion

  1. Pregnant
  2. Lactating
  3. Postmenopausal
  4. Immunosuppressed
  5. Known allergies to aloe vera or to other components of Restore
  6. Known vaginal infection that is not BV

Methods:

Over a 2 year period, women in one academic OBGYN clinic with a history of at least one prior episode of BV in the past year, (confirmed via medical records) who currently have BV diagnosed via wet mount and vaginal pH and confirmed with the Nugent score, will be approached regarding their desire to participate in the trial. If the subject chooses to participate after a thorough discussion of the risks and benefits, she will sign the informed consent and be enrolled in the trial. Demographic information will be recorded via questionnaire. A total of 20 patients will be enrolled.

Criteria

Inclusion Criteria:

  • Women aged 18-55

Exclusion Criteria:

  • Pregnant
  • Lactating
  • Postmenopausal
  • Immunosuppressed
  • Known allergies to aloe vera or to other components of Restore
  • Known vaginal infection that is not BV

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): NCT03734523


Contacts
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Contact: Wendy Strgar (541) 344-4483 wendys@goodcleanlove.com

Sponsors and Collaborators
Sexual Health and Wellness Institute

Publications:
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Responsible Party: Sexual Health and Wellness Institute
ClinicalTrials.gov Identifier: NCT03734523     History of Changes
Other Study ID Numbers: SAIRB-16-0013
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents