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

Sponsor

Gedea Biotech AB (Industry)

Overall Status

Completed

CT.gov ID

NCT03762083

Collaborator

(none)

Enrollment

Locations

Arm

10.3

Actual Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Bacterial Vaginosis	Device: pHyph, Gedea pessary	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 7, 2019

Actual Primary Completion Date :

Oct 22, 2019

Actual Study Completion Date :

Nov 18, 2019

Arms and Interventions

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.	Device: pHyph, Gedea pessary pHyph is a vaginal tablet for the treatment of BV.

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.

Device: pHyph, Gedea pessary

pHyph is a vaginal tablet for the treatment of BV.

Outcome Measures

Primary Outcome Measures

Clinical cure rate [Day 7]
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 [Day 7 compared to Day 0]
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 [Day 7]
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 [Up to day 42]
Proportion of patients answering [Yes] to the question "Have the symptoms recurred?"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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:

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