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Vaginosis, Bacterial clinical trials

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NCT ID: NCT00556179 Completed - Bacterial Vaginosis Clinical Trials

Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis

Start date: September 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to demonstrate if the use of Dermacyd can avoid the recurrence of bacterial vaginosis after three months of the standard treatment.

NCT ID: NCT00545181 Completed - Bacterial Vaginosis Clinical Trials

Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

Start date: September 2007
Phase: N/A
Study type: Interventional

Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and postpartum endometritis. Several studies have documented increased postpartum complications in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite common despite treatment. Documented recurrence rate of up to 30% within three months are reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an acidifying gel will decrease the chance of recurrence of BV within 3 months.

NCT ID: NCT00542074 Completed - Bacterial Vaginosis Clinical Trials

Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

Start date: June 2003
Phase: N/A
Study type: Interventional

Randomized controlled trial (RCT) to evaluate the effectiveness of applying Purell® (62% ethyl alcohol in emollient gel) to the penis of male partners of women diagnosed with BV for preventing BV recurrence after treatment.

NCT ID: NCT00537576 Completed - Bacterial Vaginosis Clinical Trials

Safety Study of Lactobacillus Administered Vaginally to Healthy Women

Start date: November 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the safety, tolerability, and acceptability of LACTIN-V (Active Ingredient: Lactobacillus crispatus CTV-05) with a matching placebo at three doses using pre-filled vaginal applicators in healthy pre-menopausal women. The study hypothesis is that LACTIN-V will be safe, tolerable, and acceptable at each dose and will not differ significantly from the placebo controls.

NCT ID: NCT00510614 Completed - Bacterial Vaginosis Clinical Trials

Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study

Start date: October 2007
Phase: Phase 0
Study type: Interventional

This research study is being done to evaluate the use of an oral (by mouth) medication called tinidazole to initially treat BV and then to see if additional treatment with tinidazole keeps women from getting this infection back within 3 months. Tinidazole is currently approved by the United States Food and Drug Administration (FDA) to treat bacterial vaginosis (BV). This study will evaluate the use of tinidazole to treat a woman's current BV infection and then will look at using tinidazole as a suppressive treatment (taking medication regularly to attempt to decrease the "bad" bacteria from growing back). The suppressive treatment phase will include using tinidazole twice a week compared to using placebo twice a week and then following women for recurrence of BV. The purpose of this study is to determine if tinidazole suppression will prevent BV from coming back within 3 months of treatment. The investigators hypothesize that women with a history of recurrent bacterial vaginosis who are randomized to a suppressive regimen (a dose of medication given on a regular basis to attempt to control the bacteria that causes bacterial vaginosis) of tinidazole will have lower recurrence rates and a longer time to recurrence of bacterial vaginosis when compared to those women randomized to placebo.

NCT ID: NCT00484653 Completed - Clinical trials for Vaginosis, Bacterial

Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman

Start date: July 2007
Phase: N/A
Study type: Interventional

This is a prospective multicentric study including six clinical units of Gynecology and Obstetrics (5 public health hospital and one private team), one research team in clinical microbiology and one Center of Clinical investigation (CIC). There is a correlation between premature delivery and bacterial vaginosis. So, the anomalies of vaginal flora are a potential target for the campaign against prematurity. The main objective of this study is to achieve an objective and reproducible technique of identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies. The secondary objectives are the exhaustive culture of bacteria, the characterisation of intermediate vaginal flora and bacterial vaginosis among pregnant woman by PCR targeting the ribosomic ADN 16S coupled with clonage techniques. The number of patient to include is 1000 (time of inclusions: 24 months). The vaginal smears will be realized until 32 weeks of gestation (Max: 3 taking of vaginal smears by patient).

NCT ID: NCT00464542 Completed - Bacterial Vaginosis Clinical Trials

Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study

MASH
Start date: December 2007
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT00334633 Completed - Bacterial Vaginosis Clinical Trials

Treatment of Bacterial Vaginosis (BV) With Tinidazole

Start date: November 2004
Phase: Phase 4
Study type: Interventional

We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with metronidazole

NCT ID: NCT00324818 Completed - Bacterial Vaginosis Clinical Trials

Treatment of Bacterial Vaginosis

Start date: July 2002
Phase: Phase 4
Study type: Interventional

We are trying to determine if longer duration of therapy with metronidazole or combination therapy of metronidazole plus azithromycin results in better cure rates for BV

NCT ID: NCT00318253 Completed - Bacterial Vaginosis Clinical Trials

The Effects of Cranberry Juice on Bacterial Adhesion

Start date: March 2006
Phase: N/A
Study type: Interventional

The study is based on the hypothesis that consumption of cranberry juice products results in the production of metabolites in the urine that have anti-adhesive properties on bacteria. A crossover study using 12 healthy women will be given different cranberry products or water as a control and their urine will be analyzed for anti-adhesive effects and compared to the properties of the urine. Cranberry juice will also be evaluated for its effect on vaginal microflora.