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Vaginal Diseases clinical trials

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NCT ID: NCT01089348 Recruiting - Bacterial Vaginosis Clinical Trials

A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis

LF-BV-09
Start date: July 2010
Phase: Phase 2/Phase 3
Study type: Interventional

This is a phase II multicenter randomized open-label clinical study that will determine whether treatment with Lactofiltrum (orally administered tablets) in combination with antibiotic therapy (metronidazole) is effective in women with bacterial vaginosis. Lactofiltrum is a composite drug that includes enterosorbent lignin and prebiotic Lactulose. It's supposed that supplement of Lactofiltrum to a standard therapy of bacterial vaginosis (metronidazole administered orally) improves women's general state, leads to better recovery of clinical, microbiological, biochemical and histological features of the disease.

NCT ID: NCT01055106 Completed - Vaginal Infection Clinical Trials

Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis

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

The objective of this study is to evaluate the efficacy and safety of GW05 administered in 3 regimens versus metronidazole 0.75% for the treatment of 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.

NCT ID: NCT00890487 Not yet recruiting - Vaginal Disease Clinical Trials

Hyaluronic Acid and Vaginal Distress

Start date: May 2009
Phase: N/A
Study type: Interventional

The purpose of this trial is to study the effects of the oral supplementation hyaluronic acid in menopause women with vaginal distress for treatment vaginal distress.

NCT ID: NCT00889356 Not yet recruiting - Bacterial Vaginosis Clinical Trials

Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis

Start date: September 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.

NCT ID: NCT00802386 Completed - BACTERIAL VAGINOSIS Clinical Trials

Bacterial Vaginosis Screening at IUD Insertion

Start date: January 2008
Phase:
Study type: Observational

A number of studies have shown a higher prevalence of BV among IUD users.13,,14 None, however, have screened women prior to inserting the IUD. No data exists detailing the status of the vaginal microflora and possible cervical infection prior to IUD insertion. Thus, no inference can be made about the possible influence of IUD insertion and presence to the development of upper genital tract infection . Consequently, with the current literature, it would be difficult to make an argument for screening and treatment for BV prior to IUD insertion. This study will help us determine whether women with an IUD develop a change in the normal bacteria that are present in the vagina, known as bacterial vaginosis (BV). In addition, in those women with BV, we are looking to see if they develop more significant problems with the IUD, than those who do not have BV. Overall, this will help us determine whether all women should be screened for BV prior to IUD insertion.

NCT ID: NCT00799500 Completed - Pregnancy Clinical Trials

Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing

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

Interventional study to assess the effect of early detection and treatment of bacterial vaginosis in pregnancy on preterm delivery rate.

NCT ID: NCT00799214 Completed - Bacterial Vaginosis Clinical Trials

BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) Study

Start date: April 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Bacterial vaginosis (BV), the world's most common vaginal infection, continues to cost patients time, energy, comfort and money. BV is associated with increased incidence of sexually transmitted infections (including HIV), spontaneous abortion, pre-term labour, post-surgical infections, and endometritis. Current treatment for those women symptomatic for BV includes both oral and intravaginal antibiotics, such as metronidazole, which have success rates of 70-80 % at 1 month after treatment. These treatments also have high recurrence rates (49-66 % at one year after treatment) and side effects (10-20 % of women) that include secondary vaginal infection with candida. Intravaginal boric acid has been used for >100 years for the treatment of vaginal infections and is quite commonly prescribed today as a treatment for BV. It is cheap, easily accessible, easy to use, and is an effective treatment of other vaginal infections, such as candida. To date, there are no clinical trials studying the effectiveness of boric acid in the treatment of BV. The objective of this study was to determine whether intravaginal BA is comparable to standard treatment, metronidazole, for the cure of BV in symptomatic women. Our research question is: Among women 16-50 years old symptomatic with BV is intravaginal treatment with BA non-inferior to metronidazole to achieve a Nugent score <7 (cure) by day 17. Hypothesis: H0: BA proportion of women cured < metronidazole proportion of women cured - 10%.

NCT ID: NCT00741845 Terminated - Bacterial Vaginosis Clinical Trials

Prevention of Persistence of Bacterial Vaginosis

Start date: June 2008
Phase: Phase 3
Study type: Interventional

This purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole + 200mg miconazole) and low dose (37.5mg) intravaginal metronidazole, with the rate of persistent bacterial vaginosis.

NCT ID: NCT00729469 Completed - Atrophy Clinical Trials

Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity

Start date: July 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.