Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis

November 21, 2019 updated by: Gedea Biotech AB

An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Bacterial Vaginosis

This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with confirmed BV according to fulfillment of at least 3 of the 4 Amsel criteria. On Day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. Patients will be examined after 7 days with respect to 3 Amsel criteria (the criterion: "pH of vaginal fluid above 4.5" is only included at study inclusion for diagnosis), and if not cured, will receive prolonged treatment for one additional week. Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal samples will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing BV symptoms, usability, and adverse events (AEs).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Helsingborg, Sweden
        • Stortorgets Gynekologmottagning
      • Lund, Sweden
        • Sophiakliniken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Adult, post-menarchal, pre-menopausal women aged 18 years or older

  • Diagnosis of BV according to Amsel's criteria, defined as having at least 3 of the 4 following criteria:

    1. Thin, white, yellow, homogenous discharge
    2. Clue cells on microscopy (more than 20 percent of epithelial cells)
    3. pH of vaginal fluid above 4.5
    4. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added
  • Having decisional capacity and providing written informed consent
  • Negative urine pregnancy test at screening
  • Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period
  • Refrain from sexual intercourse or use a condom until Day 7
  • Signed informed consent and willing and able to comply with all study requirements

Exclusion Criteria:

Patients with known or apparent signs of other infectious causes of BV (vulvovaginal candidiasis, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening

  • Anticipated menstruation during the treatment period (Day 0 till Day 7)
  • Patients who are pregnant or breastfeeding
  • Patients who were treated for BV within the past 14 days
  • Patients who are currently receiving antibiotic therapy unrelated to BV or have received antibiotic therapy within the past 14 days
  • Patients who have used pH-modifying vaginal products within the last 14 days
  • Patients who have received an investigational drug in a clinical investigation within 30 days prior to screening
  • Known/previous allergy or hypersensitivity to any product constituent
  • Any medical condition that in the Investigator's judgments would make the patient unsuitable for inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pHyph, Gedea Pessary
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of BV.
pHyph is a vaginal tablet for the treatment of BV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical cure rate
Time Frame: Day 7

Defined as absence of all of the following 3 Amsel criteria:

  1. Thin, white, yellow, homogenous discharge
  2. Clue cells on microscopy (more than 20% of epithelial cells)
  3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability, measured by patient questionnaire
Time Frame: Day 7
General assessment of the treatment [1-10, where 10 is very pleased and 1 is very unpleased]
Day 7
Proportion of patients being negative for each of the 3 Amsel criteria
Time Frame: Day 7 compared to Day 0

Defined as absence of the following Amsel criteria:

  1. Thin, white, yellow, homogenous discharge
  2. Clue cells on microscopy (more than 20% of epithelial cells)
  3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added
Day 7 compared to Day 0
Proportion of patients having a recurrence of the BV
Time Frame: Up to day 42
Proportion of patients answering [Yes] to the question "Have the symptoms recurred?"
Up to day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Monika Cardell, MD, PhD, Kvinnokliniken, Region Skåne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2019

Primary Completion (Actual)

October 22, 2019

Study Completion (Actual)

November 18, 2019

Study Registration Dates

First Submitted

November 30, 2018

First Submitted That Met QC Criteria

November 30, 2018

First Posted (Actual)

December 3, 2018

Study Record Updates

Last Update Posted (Actual)

November 22, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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