Bacterial Vaginosis Clinical Trial
Official title:
Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 Shedding
An important contributor to the epidemic spread of herpes simplex virus type 2 (HSV-2) is
its high frequency of asymptomatic shedding in the genital tract, as transmission usually
occurs during these periods of subclinical reactivation of the virus (1). Therefore, an
improved understanding of the risk factors associated with HSV-2 shedding is needed.
The researchers' preliminary data suggests that bacterial vaginosis (BV) may be associated
with increased genital tract shedding of HSV-2 (2). As BV is the most common cause of
vaginal symptoms in reproductive age women, even modest associations with genital tract
shedding of HSV-2 would result in substantial attributable risks for transmission of the
virus.
The researchers' investigation will assess the effects of asymptomatic BV on daily genital
tract shedding of HSV-2 by determining shedding frequency before and after treatment of
asymptomatic BV. To do this, the researchers will enroll 35 HSV-2 seropositive women with
asymptomatic BV. These women will be instructed to self-collect daily swab specimens for
HSV-2 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) analysis from the lower
genital tract for one month. At the end of the one month follow-up visit, each participant
will complete a one week course of oral metronidazole for treatment of BV. This will be
followed by daily home collection of genital tract swab specimens for an additional one
month.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
NCT00556179 -
Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis
|
Phase 4 | |
| Completed |
NCT00545181 -
Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
|
N/A | |
| 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 |