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

Primary Purpose

Bacterial Vaginosis

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

pHyph, Gedea pessary

About this trial

This is an interventional treatment trial for Bacterial Vaginosis focused on measuring vaginitis, vaginal disease, vulvovaginitis, genital disease, female, vaginitis, bacterial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Stortorgets Gynekologmottagning
Sophiakliniken

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pHyph, Gedea Pessary

Arm Description

Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of BV.

Outcomes

Primary Outcome Measures

Clinical cure rate

Defined as absence of all of the following 3 Amsel criteria: Thin, white, yellow, homogenous discharge Clue cells on microscopy (more than 20% of epithelial cells) Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added

Secondary Outcome Measures

Proportion of patients being negative for each of the 3 Amsel criteria

Defined as absence of the following Amsel criteria: Thin, white, yellow, homogenous discharge Clue cells on microscopy (more than 20% of epithelial cells) Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added

Usability, measured by patient questionnaire

General assessment of the treatment [1-10, where 10 is very pleased and 1 is very unpleased]

Proportion of patients having a recurrence of the BV

Proportion of patients answering [Yes] to the question "Have the symptoms recurred?"

Full Information

NCT ID

NCT03762083

First Posted

November 30, 2018

Last Updated

November 21, 2019

Sponsor

Gedea Biotech AB

1. Study Identification

Unique Protocol Identification Number

NCT03762083

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

January 7, 2019 (Actual)

Primary Completion Date

October 22, 2019 (Actual)

Study Completion Date

November 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gedea Biotech AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Vaginosis

Keywords

vaginitis, vaginal disease, vulvovaginitis, genital disease, female, vaginitis, bacterial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pHyph, Gedea Pessary

Arm Type

Experimental

Arm Description

Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of BV.

Intervention Type

Device

Intervention Name(s)

pHyph, Gedea pessary

Intervention Description

pHyph is a vaginal tablet for the treatment of BV.

Primary Outcome Measure Information:

Title

Clinical cure rate

Description

Time Frame

Day 7

Secondary Outcome Measure Information:

Title

Proportion of patients being negative for each of the 3 Amsel criteria

Description

Time Frame

Day 7 compared to Day 0

Title

Usability, measured by patient questionnaire

Description

General assessment of the treatment [1-10, where 10 is very pleased and 1 is very unpleased]

Time Frame

Day 7

Title

Proportion of patients having a recurrence of the BV

Description

Proportion of patients answering [Yes] to the question "Have the symptoms recurred?"

Time Frame

Up to day 42

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Thin, white, yellow, homogenous discharge Clue cells on microscopy (more than 20 percent of epithelial cells) pH of vaginal fluid above 4.5 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Monika Cardell, MD, PhD

Organizational Affiliation

Kvinnokliniken, Region Skåne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stortorgets Gynekologmottagning

City

Helsingborg

Country

Sweden

Facility Name

Sophiakliniken

City

Lund

Country

Sweden

12. IPD Sharing Statement

Links:

URL

http://gedeabiotech.com

Description

Sponsor webpage

Learn more about this trial

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

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