Probiotics for the Prevention of Premature Birth and Neonatal Related Morbidity
Bacterial VaginosisPremature Birth3 moreThe trial intends to evaluate the efficacy of specially designed probiotics to prevent premature birth and related neonatal morbidity associated to intra-uterine infection. The tested probiotics are efficacious to decrease the prevalence of bacterial vaginosis. The study hypothesis is that the early administration of those probiotics to pregnant women with bacterial vaginosis can prevent premature birth through antibiotic activity and modulation of the immune response to infection.
Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy
VaginosisBacterial3 moreThe goal of this study is to examine acceptability and efficacy of 2 kinds of BV treatment among women at low risk for preterm delivery. The objectives are: To examine the side effects and patient acceptability of oral versus intravaginal metronidazole. To compare the efficacy of oral and intravaginal metronidazole for the treatment of BV To study the efficacy of oral and intravaginal metronidazole for the prevention of hospital admission during the 3rd trimester, chorioamnionitis, preterm delivery, and maternal infectious morbidity.
Treatment of Bacterial Vaginosis With Oral Tinidazole
Bacterial VaginosisThe purpose of this study is to confirm the safety and efficacy of oral tinidazole for the treatment of bacterial vaginosis.
Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy...
AtrophyVaginal DiseasesThe objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.
Suppression Of Bacterial Vaginosis (BV) [SUBVert]
Bacterial VaginosisA Phase II randomized, double-blind, placebo-controlled study screening approximately 600 adult females, aged 18-55, with a goal to enroll approximately 250 participants to achieve 200 evaluable participants at the test of cure (TOC) visit. The study is designed to determine the clinical efficacy of an investigational product (IP), TOL-463 Insert, in suppressing Recurrent Bacterial Vaginosis (RBV) when administered to women who have a history of RBV and have been successfully cleared of their current Bacterial Vaginosis (BV) infection administering 500 mg of oral metronidazole, twice a day for 7 days or another CDC-recommended BV treatment. Patient participation will be approximately 100 days while the study is conducted at 4 sites within the United States. The primary objective of the study is to evaluate the clinical efficacy of a twice-weekly application of TOL-463 vaginal insert in suppression of BV in women with a history of RBV following successful induction with oral metronidazole or a CDC-recommended BV treatment.
Evaluation of Gynecological Acceptability of a Health Care Product
Atrophic VaginitisVaginal DiseasesThe research will be conducted with a product for use in the intimate region in up to 75 research participants who will use the investigational product for 28 ± 2 days. Will be evaluated and followed up throughout the study by a gynecologist to verify the safety and effectiveness of the product and possible adverse events. The study will evaluate the non-interference of a topical use product on the intimate area, helping to preserve the natural defenses. In addition, the epithelial hydration and pH of the intimate area will be evaluated.
Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®
Vaginal DiseaseThis study evaluates treatment with the medical device Ainara® compared to a HA-based gel (Hyalogin) on the improvement of vaginal dryness
Evaluation of Gynecological Acceptability of 3 Health Care Products
Atrophic VaginitisVaginal DiseaseThe research was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35 ± 2 days. The subjects were follow up throughout the study by a gynecologist for verification of safety, effectiveness and possible adverse events.
Post Marketing Follow Up Study To Evaluate Performance Safety Quality of Menopausal Transition Women...
Vaginal DiseaseThe objective of the present PMCF study with a 6 month follow up period is to identify potential new and unknown risks associated with longer term use of Ainara® and (considering the duration of symptoms in GSM) to collect additional data regarding efficacy of a long-term treatment with this medical device.
Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis
VaginosisBacterial1 moreThe 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.