- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03762083
Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis
An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Bacterial Vaginosis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Helsingborg, Sweden
- Stortorgets Gynekologmottagning
-
Lund, Sweden
- Sophiakliniken
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
pHyph is a vaginal tablet for the treatment of BV.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical cure rate
Time Frame: Day 7
|
Defined as absence of all of the following 3 Amsel criteria:
|
Day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability, measured by patient questionnaire
Time Frame: Day 7
|
General assessment of the treatment [1-10, where 10 is very pleased and 1 is very unpleased]
|
Day 7
|
Proportion of patients being negative for each of the 3 Amsel criteria
Time Frame: Day 7 compared to Day 0
|
Defined as absence of the following Amsel criteria:
|
Day 7 compared to Day 0
|
Proportion of patients having a recurrence of the BV
Time Frame: Up to day 42
|
Proportion of patients answering [Yes] to the question "Have the symptoms recurred?"
|
Up to day 42
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Monika Cardell, MD, PhD, Kvinnokliniken, Region Skåne
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QRS-CL2-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bacterial Vaginosis
-
CDA Research Group, Inc.TerminatedBacterial Vaginosis (BV)United States
-
Zagazig UniversityRecruitingBacterial Vaginosis | Vaginal | MicrobiologyEgypt
-
Starpharma Pty LtdCompletedRecurrent Bacterial Vaginosis (BV)
-
Alfasigma S.p.A.ParexelTerminatedBACTERIAL VAGINOSISUnited States
-
University of Alabama at BirminghamWayne State UniversityCompletedRecurrent Bacterial VaginosisUnited States
-
Zagazig UniversityUnknownBacterial Vaginosis TreatmentEgypt
-
Unity Health TorontoCompleted
-
Mount Sinai Hospital, CanadaUnity Health TorontoCompletedPregnant Women Who Test Positive for Bacterial VaginosisCanada
-
Universiti Kebangsaan Malaysia Medical CentreNot yet recruitingBacterial Vaginoses
-
National Institute of Allergy and Infectious Diseases...Completed
Clinical Trials on pHyph, Gedea pessary
-
Gedea Biotech ABCompletedVulvovaginal CandidiasisSweden
-
Gedea Biotech ABActive, not recruitingVulvovaginal CandidiasisSweden
-
Gedea Biotech ABCompletedBacterial VaginosisUnited Kingdom, Sweden
-
Gedea Biotech ABRecruiting
-
Zeynep Kamil Maternity and Pediatric Research and...Unknown
-
Bürgerhospital FrankfurtNot yet recruitingPremature Birth | Preterm BirthGermany, Spain, Australia, Greece
-
Bürgerhospital FrankfurtNot yet recruitingPremature Birth | Preterm BirthGermany, Spain, Australia, Greece
-
Federico II UniversityTerminated
-
The George Washington University Biostatistics...Eunice Kennedy Shriver National Institute of Child Health and Human Development...TerminatedPreterm Delivery | Short CervixUnited States
-
NICHD Pelvic Floor Disorders NetworkCompletedUrinary Incontinence | Stress Urinary IncontinenceUnited States