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Bacterial Vaginosis clinical trials

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NCT ID: NCT01450462 Completed - Bacterial Vaginosis Clinical Trials

Vitamin D and Sexual Health

DASH
Start date: September 2011
Phase: N/A
Study type: Interventional

Bacterial vaginosis (BV) develops when the concentration of healthy Lactobacillus species in the vagina declines and is replaced by other bacterial species. BV is the most common vaginal infection worldwide, but the etiology of this complex condition is not clear. BV is associated with a 60% increased risk of HIV acquisition as well as numerous other detrimental reproductive outcomes. A profound racial disparity exists in BV prevalence in women in the United States (US): 23% of white women versus. 52% of black women have BV. The investigators hypothesize that inadequate vitamin D contributes to BV development and/or recurrence. Vitamin D is essential to immune function, serving both to stimulate mechanisms associated with pathogen elimination and to regulate immune response. According to nationally-representative data, 90% of US blacks have insufficient vitamin D levels. In two recent analyses, low vitamin D was associated with higher BV prevalence in pregnant African-Americans; a third replicated this finding in pregnant African-American and white women. The investigators wish to conduct a small, pilot randomized controlled trial (RCT) to assess the effect of vitamin D supplementation among non-pregnant, BV-positive women at a public sexually transmitted disease (STD) clinic. This small (n=150), two-arm, placebo-controlled, masked, 24-week RCT of high-dose vitamin D supplementation will inform the development of future large-scale RCT design and implementation.

NCT ID: NCT01347632 Completed - Bacterial Vaginosis Clinical Trials

Study of How Bacterial Vaginosis and Its Treatment Affects Cervical and Vaginal Tissue

CONRADBV
Start date: April 2011
Phase: N/A
Study type: Interventional

This is a research study to determine whether bacterial vaginosis (BV) changes the cervico-vaginal tissue (skin covering the cervix and vagina) and makes women at higher risk for getting HIV (Human Immunodeficiency Virus). Vaginal and cervical tissue biopsies from women with BV will be obtained and infected OUTSIDE the body (ex vivo) with HIV. BV is a vaginal infection that develops when there is an imbalance in the normal bacteria found in a woman's vagina. It is the most common cause of vaginal discharge among women of child-bearing age. BV infections potentially harm the safety of the tissue surrounding the cervico-vaginal region. When the cervico-vaginal tissue is not well protected, the risk of acquiring HIV from an infected partner might increase significantly. Studies have shown that HIV is more common in women with BV than in women with normal vaginal bacteria. Treatment of BV typically involves the use of antibiotics. Antibiotics kill harmful bacteria and provide a temporary relief from the symptoms caused by the infection. Women participating in this study will use the generic antibiotic metronidazole, also known as Flagyl. The Center for Disease Control and Prevention (CDC) recommends Flagyl for the treatment of BV. The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3 different time periods: 1. During a BV infection 2. Approximately 1 week after completing a 7-day course of metronidazole therapy 3. Approximately 1 month after completing the 7-day course of metronidazole therapy You will not come in contact with HIV during this study - only your samples (after we have removed them from your vagina/cervix) come in contact with HIV.

NCT ID: NCT01335373 Completed - Bacterial Vaginosis Clinical Trials

Observational Program Neo-Penotran® Forte

Start date: October 2010
Phase: N/A
Study type: Observational

Vaginitis is the most common gynecologic diagnosis in the primary care setting. In approximately 90 percent of affected women, this condition occurs secondary to bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis or mixed infection. Neo-Penotran Forte is registered for treatment of these most common vaginal infections. Efficacy and safety of this product is already established, and this observational study was designed to learn more about practical use of Neo-Penotran® Forte in real life setting.

NCT ID: NCT01258556 Completed - Bacterial Vaginosis Clinical Trials

The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis

Start date: June 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Purpose of the proposed research is to determine the impact of probiotic yogurt supplemented with Lactobacillus rhamnosus (Fiti) compared to regular yogurt on the well-being of women living with HIV.

NCT ID: NCT01245322 Completed - Bacterial Vaginosis Clinical Trials

Treatment of Bacterial Vaginosis Combined With Human Lactobacilli

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

The primary objectives of this study were to characterize lactobacilli of human vaginal origin and to investigate if more extended antibiotic treatment against Bacterial Vaginosis, together with adjuvant lactobacilli treatment, could increase the cure rate and furthermore, to investigate factors that could influence relapse.

NCT ID: NCT01230814 Completed - Bacterial Vaginosis Clinical Trials

Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women

Start date: April 2011
Phase: Phase 2
Study type: Interventional

This research study is about vaginal infections such as bacterial vaginosis, yeast infections, and trichomoniasis. Usually, these infections can be treated with medication, but sometimes they come back after treatment. Researchers want to know if using vaginal suppositories can decrease the risk of vaginal infections. Participants will include 234 women who are sexually active (greater than or equal to 4 episodes of sex with men during the past month), HIV-negative, 18 to 45 years old, with bacterial infection [vaginosis and/or vulvovaginal candidiasis (VVC) and/or Trichomonas vaginalis] detected by laboratory testing at a screening visit. Women will receive vaginal suppositories containing drug or inactive ingredients (placebo). Participation in the study will be about 12 months. Study procedures include: urine and blood tests, physical exams, and questionnaires.

NCT ID: NCT01201057 Completed - Bacterial Vaginosis Clinical Trials

Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)

Start date: August 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.

NCT ID: NCT01160796 Completed - Bacterial Vaginosis Clinical Trials

Lcr35® for Bacterial Vaginosis Prevention

Start date: June 2010
Phase: Phase 3
Study type: Interventional

This is a national, multi-centre, randomized, double-blind placebo-controlled, phase III superiority trial. The main objective of the trial is to assess the efficacy of Lcr35® by comparing the mean time before the onset of the first clinical recurrence confirmed by laboratory tests in patients with bacterial vaginosis treated with Lcr35® versus placebo. Patients with bacterial vaginosis will be enroll by private gynecologists. Each patient will receive a treatment for the initial episode(Metronidazole)and a treatment to prevent the recurrence of bacterial vaginosis (Lcr35®).

NCT ID: NCT01125410 Completed - Bacterial Vaginosis Clinical Trials

Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis

Start date: January 2007
Phase: Phase 3
Study type: Interventional

The purpose of this clinical study was to evaluate whether vaginal tablets containing 10 mg dequalinium chloride (Fluomizin) are comparable in clinical efficacy and safety to clindamycin vaginal cream (2%) in patients suffering from bacterial vaginosis.

NCT ID: NCT01020396 Completed - Bacterial Vaginosis Clinical Trials

Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis

Start date: January 2002
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study was to demonstrate comparable efficacy, safety, and tolerability of Teva Pharmaceuticals USA's generic formulation of Metronidazole Vaginal Gel, 0.75% and 3M Pharmaceuticals' MetroGel-Vaginal® metronidazole vaginal gel, 0.75% to establish clinical equivalence in the treatment of bacterial vaginosis.