Clinical trial NCT03762083: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Vaginosis
Keywords: vaginitis
vaginal disease
vulvovaginitis
genital disease, female
vaginitis, bacterial
Lead sponsor: Gedea Biotech AB
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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:

  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

Primary outcomes:
measure: Clinical cure rate
timeFrame: Day 7
Secondary outcomes:
measure: Proportion of patients being negative for each of the 3 Amsel criteria
timeFrame: Day 7 compared to Day 0
measure: Usability, measured by patient questionnaire
timeFrame: Day 7
measure: Proportion of patients having a recurrence of the BV
timeFrame: Up to day 42
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Stortorgets Gynekologmottagning
city: Lund
country: Sweden
facility: Sophiakliniken
Study officials:
affiliation: Kvinnokliniken, Region Skåne
name: Monika Cardell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: