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

Not Applicable

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Device: pHyph, Gedea pessary

• Registration Number: NCT03762083
• Lead Sponsor: Gedea Biotech AB

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-30
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-03
• Study Start: 2019-01-07
• Primary Completion: 2019-10-22
• Status Verified: 2019-11
• Study Completion: 2019-11-18
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinical cure rate	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

Secondary Outcome Measures

Name	Time	Method
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: 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
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?"

Trial Locations

Locations (2)

Stortorgets Gynekologmottagning; 🇸🇪 Helsingborg, Sweden

Sophiakliniken; 🇸🇪 Lund, Sweden