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Vaginal Diseases clinical trials

View clinical trials related to Vaginal Diseases.

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NCT ID: NCT04370548 Completed - Bacterial Vaginosis Clinical Trials

DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)

Start date: June 16, 2020
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled study of DARE-BV1 (clindamycin phosphate vaginal gel, 2%) (QD x 1 day) compared to placebo vaginal gel (HEC Universal Placebo Gel) (QD × 1 day) for the treatment of bacterial vaginosis. Patients will be evaluated at three time points: a Day 1 Screening/Randomization visit, a Day 7-14 Interim Assessment visit, and a Day 21 - 30 Test of Cure [TOC] visit). Patients who discontinue prematurely from the study will receive a safety follow-up phone call between Day 21-30. The total study duration will be approximately one month for each individual patient.

NCT ID: NCT04362371 Completed - Vaginal Disease Clinical Trials

Post Marketing Follow Up Study To Evaluate Performance Safety Quality of Menopausal Transition Women Treated With Ainara

Start date: June 27, 2019
Phase: N/A
Study type: Interventional

The 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.

NCT ID: NCT04329338 Completed - Bacterial Vaginoses Clinical Trials

Effects of Lactobacillus Pentosus KCA1 on the Gut and Vaginal Microbiome of Women With Bacterial Vaginosis

Start date: November 8, 2017
Phase: N/A
Study type: Interventional

Bacterial vaginosis (BV) is under-reported, misdiagnosed and inappropriately treated in Nigeria. Treatment option rely on antibiotics that eliminates both good and pathogenic bacteria, with gross impact on the gut and vaginal microbiome. Our primary objective in this study is to determine the effects of Lactobacillus on the gut and vagina when taken orally.

NCT ID: NCT04327947 Completed - Atrophic Vaginitis Clinical Trials

Evaluation of Gynecological Acceptability of 3 Health Care Products

Start date: November 6, 2019
Phase: N/A
Study type: Interventional

The 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.

NCT ID: NCT04287504 Recruiting - Preterm Birth Clinical Trials

Point-of-care Tests for Bacterial Vaginosis and Candidosis

Start date: February 14, 2020
Phase:
Study type: Observational

Vaginal infection in early pregnancy is associated with an increased risk of spontaneous preterm delivery and late miscarriage. Most studies presume that vaginal infections are responsible for up to 40% of preterm birth. Although the causative microorganisms of vaginal infections are manifold, the three pathogens most commonly associated with vaginal infections are Gardnerella vaginalis, Candida albicans and Trichomonas vaginalis. The aim of this prospective study is the validation of the point-of-care tests OSOM BVBLUE for bacterial vaginosis and SavvyCheck Vaginal Yeast Test for candidosis in comparison to Gram stain.

NCT ID: NCT04247022 Completed - Atrophic Vaginitis Clinical Trials

Evaluation of Gynecological Acceptability of a Health Care Product

Start date: April 9, 2021
Phase: N/A
Study type: Interventional

The 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.

NCT ID: NCT04245358 Completed - Vaginal Disease Clinical Trials

Open Non-Comparative Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®

Start date: September 20, 2019
Phase: N/A
Study type: Interventional

This 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.

NCT ID: NCT04245293 Completed - Vaginal Disease Clinical Trials

Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®

Start date: April 11, 2019
Phase: N/A
Study type: Interventional

This study evaluates treatment with the medical device Ainara® compared to a HA-based gel (Hyalogin) on the improvement of vaginal dryness

NCT ID: NCT04189744 Completed - Bacterial Vaginoses Clinical Trials

The ASPIRE Trial - Aiming for Safe Pregnancies by Reducing Malaria and Infections of the Reproductive Tract

Start date: December 15, 2019
Phase: Phase 3
Study type: Interventional

Malaria in pregnancy has devastating consequences for mother and foetus. WHO recommends intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) for asymptomatic women, but high-level parasite resistance to SP threatens its efficacy. Dihydroartemisinin-piperaquine (DP) has the potential to replace SP for IPTp. However, the DP strategy has not been found to be superior to SP for reducing the incidence of low birthweight (LBW), small-for-gestational age (SGA), or preterm birth. This may be the result of sulphadoxine having antibacterial properties; it is derived from sulphonamide, which have been used for decades to treat curable STIs/RTIs. However, SP is unlikely to be curative of STIs/RTIs, nor highly effective against malaria parasites. Thus, combination treatment that contains a more efficacious antimalarial and a more efficacious anti-STI/RTI may produce better birth outcomes. The investigators will therefore determine whether combining SP with metronidazole (MTZ) or, separately, DP with MTZ can improve birth outcomes more than SP alone, potentially paving the way for integrated control strategies that will reduce the dual burden of malaria and curable STIs/RTIs. This is an individually-randomized, 3-arm, partially-placebo controlled superiority trial comparing the efficacy, safety and tolerance of IPTp-SP versus IPTp-SP with MTZ, or IPTp-DP with MTZ to reduce adverse birth outcomes attributable to malaria and curable STIs/RTIs in 5,436 women in the Nchelenge District of Zambia.

NCT ID: NCT04057482 Completed - Bacterial Vaginoses Clinical Trials

Treatment of BV With Donaxyl and a Molecular Test of Cure

Start date: May 2015
Phase:
Study type: Observational

. Treatment with dequalinium chloride vaginal tablets for 6 days had a cure rate lower than expected; only 37% of patients were considered cured one month after treatment.