
BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) Study
Bacterial VaginosisBacterial 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%.

Study of the Management of Vaginal Discharge in West African Using Single Dose Treatments
Bacterial VaginosisCandidiasis1 moreThis randomised controlled trial aimed to verify whether directly observed single dose treatment (with tinidazole+fluconazole) would be as effective as the longer standard treatments (metronidazole for 7 days, plus vaginal clotrimazole for 3 days) in the syndromic management of women presenting with vaginal discharge in primary health care centers of Ghana, Togo, Guinea and Mali. It was designed as an effectiveness trial, i.e. it was done under conditions typical of routine work in these health centers

Open Non-Comparative Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®
Vaginal DiseaseThis study evaluates treatment with the medical device Ainara on the improvement of vaginal dryness evaluated by Vaginal Health Index (VHI) and Visual Analog Scale (VAS) in comparison with the baseline condition.

Single Arm Study of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial VaginosisOpen, single arm trial that intends to confirm the safety and efficacy of Multi-Gyn ActiGel Plus for treatment of Bacterial Vaginosis. Adult women will be diagnosed by the gynaecologist based on the Amsel criteria at day 0. They will use the product for 7 days and will come to the practice at day 21. The primary endpoint is the clinical cure rate of Bacterial Vaginosis at 3 weeks after start of treatment.

Vaginal and Rectal Colonization of Lactobacillus Crispatus NTCVAG04 Following Oral Administration...
VaginitisVaginosisThe purpose of this study is to identify the presence of L. Crispatus in the rectum and vagina after oral administration of BIOVAGINIL by searching for specific DNA of the bacterial strain, to evaluate the tolerability of BIOVAGINIL and evaluate the minimum duration of the oral administration necessary to determine the appearance of L. Crispatus.

Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of...
Bacterial VaginosisThis is a Phase II, Double-Blind, Randomized, Placebo-Controlled, Multi-center Trial enrolling 120 subjects with Bacterial Vaginosis who will be randomized at a ratio of 2:1 to receive active test article (5% Monolaurin Vaginal Gel) or placebo (vehicle). The primary objective is to assess the safety and tolerability of 5% Monolaurin Vaginal Gel compared to vehicle placebo gel (excipients only) and to assess the efficacy by clinical cure rate of 5% Monolaurin Vaginal Gel compared to vehicle placebo gel at Visit 2.

Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
Bacterial VaginosisThis is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent girls with bacterial vaginosis.

Safety and Tolerability of Metronidazole Gel 1.3%
VaginosisBacterialMulticenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal Gel in females 12 to <18 years for the treatment of bacterial vaginosis.

TOL-463 Phase 2 Study for Vaginitis
Bacterial VaginosisVulvovaginal CandidiasisThis is a Phase II study designed to assess the safety and efficacy of an investigational product, TOL-463, to treat vaginitis.

Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections
CandidiasisVaginosis1 moreThe purpose of this study is to determine whether a formula of boric acid and probiotics for vaginal application is effective in the treatment of symptomatic episodes of vulvovaginitis in comparison to pharmacological reference controls (depending on the suspected diagnosis).