Status:
COMPLETED
Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis
Lead Sponsor:
Gedea Biotech AB
Conditions:
Bacterial Vaginosis
Eligibility:
FEMALE
18+ years
Phase:
NA
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 bacterial vaginosis (BV) according ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03762083
Start Date
January 7 2019
End Date
November 18 2019
Last Update
July 25 2025
Active Locations (2)
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1
Stortorgets Gynekologmottagning
Helsingborg, Sweden
2
Sophiakliniken
Lund, Sweden