Bacterial Vaginosis Clinical Trial
Official title:
A Randomised, Partly-blinded Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Bacterial Vaginosis Compared With an Untreated Control Group
This is a randomised, parallel group, partly blinded investigation to evaluate the clinical performance and safety of pHyph in adult women with bacterial vaginosis. Patients will be randomised to active treatment or no treatment (untreated controls) in a 1:1 ratio. The Investigators carrying out the gynaecological assessments will be blinded. Patients will not be blinded. The population of this investigation will consist of post-menarchal, pre-menopausal females 18 years or older seeking treatment for BV symptoms ("fishy smell", irritation and burning). Approximately 82-92 patients will be recruited and randomised. BV will be diagnosed according to Amsel's criteria, defined as having at least 3 of the 4 criteria. Active treatment (from the start of the investigation) will be compared to no treatment at day 7 after screening (primary endpoint). Clinical cure rate on Day 7 is defined as the absence of all of the following 3 Amsel criteria: - Thin, white, yellow, homogeneous discharge. - Clue cells on microscopy (>20% of epithelial cells). - Release of a "fishy odour", i.e., a positive "whiff test" when alkali (10% KOH solution) is added. Patients receiving rescue treatment before Day 7 will be considered as treatment failures. Patients in the "no treatment group" will receive pHyph as rescue treatment if they are not cured day 7. They will thereafter follow the same scheme as the patients starting with pHyph treatment. After the initial pHyph treatment, daily during 6 days, patients will continue with pHyph twice weekly until day 25 when an additional assessment will be performed. If the patients are cured, they will continue to receive pHyph as preventive treatment during 6 weeks and possible BV recurrences will be assessed.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03930745 -
Suppression Of Bacterial Vaginosis (BV) [SUBVert]
|
Phase 2 | |
Completed |
NCT02863536 -
A Study of the New Medical Device Polybactum®
|
N/A | |
Completed |
NCT03187457 -
PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"
|
N/A | |
Recruiting |
NCT02185456 -
Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis
|
Phase 0 | |
Completed |
NCT02150655 -
Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women
|
Phase 0 | |
Completed |
NCT01450462 -
Vitamin D and Sexual Health
|
N/A | |
Recruiting |
NCT01558388 -
Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy
|
Phase 4 | |
Not yet recruiting |
NCT00889356 -
Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis
|
Phase 3 | |
Completed |
NCT01471457 -
Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis
|
Phase 2/Phase 3 | |
Completed |
NCT00545181 -
Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
|
N/A | |
Completed |
NCT00556179 -
Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis
|
Phase 4 | |
Completed |
NCT02236156 -
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
|
Phase 3 | |
Not yet recruiting |
NCT05434104 -
The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study
|
N/A | |
Completed |
NCT01335373 -
Observational Program Neo-Penotran® Forte
|
N/A | |
Completed |
NCT00752193 -
Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System.
|
N/A | |
Active, not recruiting |
NCT00536848 -
The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients
|
Phase 2/Phase 3 | |
Completed |
NCT00510614 -
Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study
|
Phase 0 | |
Suspended |
NCT00207480 -
Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women
|
Phase 1 | |
Recruiting |
NCT05278130 -
Serial Screening and Treatment of Bacterial Vaginosis Trial
|
N/A | |
Completed |
NCT02905890 -
The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis
|
Phase 4 |