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

Bacterial Vaginosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03762083
• Other study ID #: QRS-CL2-003
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: November 18, 2019

Study information

• Verified date: November 2019
• Source: Gedea Biotech AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 18, 2019
• Est. primary completion date: October 22, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

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

Locations

Country	Name	City	State
Sweden	Stortorgets Gynekologmottagning	Helsingborg
Sweden	Sophiakliniken	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Gedea Biotech AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 7
Secondary	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	Day 7 compared to Day 0
Secondary	Usability, measured by patient questionnaire	General assessment of the treatment [1-10, where 10 is very pleased and 1 is very unpleased]	Day 7
Secondary	Proportion of patients having a recurrence of the BV	Proportion of patients answering [Yes] to the question "Have the symptoms recurred?"	Up to day 42

External Links

•   Sponsor webpage