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Vaginitis clinical trials

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NCT ID: NCT05828498 Completed - Bacterial Vaginitis Clinical Trials

The Mediterranean Diet and Bacterial Vaginitis

Start date: December 1, 2022
Phase:
Study type: Observational

This study aimed to determine the effect of the Mediterranean diet as medical nutrition therapy in addition to medical therapy in patients diagnosed with vaginitis.

NCT ID: NCT05670535 Completed - Sexual Dysfunction Clinical Trials

Sjögren and Gynecologic Considerations

Start date: March 1, 2021
Phase:
Study type: Observational

Sjögren's syndrome is an autoimmune disorder characterized by glandular and extra-glandular manifestations. It is called primary Sjögren's syndrome (pSS) in absence of another connective tissue disease. The hallmark symptoms of pSS are dry eyes and dry mouth due to the decreased lacrimal and salivary gland functions. However, other tissue and organs may also be involved which precede such as xerotrachea in upper airway, atrophic gastritis and pancreatitis in gastrointestinal tract, and dryness in vaginal mucosa. Regarding to the genital involvement in pSS, vaginal dryness and resultant vaginal discomfort, and pain are reported as the common complaints. The transudate released by vaginal mucosa is the main resource of vaginal secretions.The human microbiome was reported to have a potential impact in etiopathogenesis of certain autoimmune disorders. The previous research revealed significant alterations in the gut, eye, and oral flora of the pSS patients. The disturbed oral flora due to immunodeficiency and reduced salivary flow was also reported to make the SS patients to prone to bacterial infections and recurrent oral candidiasis. Vaginitis has been defined as a spectrum of symptoms suggesting vulvovaginal discomfort such as itching, burning, irritation, and abnormal discharge. Even the vaginitis is an evidence of disturbance in vaginal flora, previous prospective research on vaginal microbiome of pSS patients either excluded the cases with vaginitis or not mentioned from the presence of vaginitis in women with pSS. To the best of our knowledge, there has not been any study yet to define the characteristics of vaginal flora through the presence of clinical signs and symptoms in women with pSS. To gain more insight into the clinical context of the gynecologic complaints, sexual dysfunction, and presence of vaginitis in pSS, the current study aims to identify the associations between these issues and pSS related disease parameters.

NCT ID: NCT05666778 Recruiting - Bacterial Vaginosis Clinical Trials

Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs

POWWERHealth
Start date: February 13, 2023
Phase: Phase 2
Study type: Interventional

HIV remains a global pandemic with 37 million infected. In western Kenya, 16% of women in the general population and 29% of the poorest women have HIV. The HIV and sexually transmitted infection (STI) epidemics overlap with broader reproductive health concerns. Menstrual hygiene management is a big problem in low- and middle-income countries and a lack of menstrual products negatively impacts women's work-life. This comes from cultural taboos, stigma, and discrimination, promoting secrecy around menstruation, high cost of menstrual products, use of traditional materials (e.g. rags, cotton wool, etc.) causing leakage and odor, and lack of water and safe hygiene facilities. Menstrual cups designed for use during sex may help women prevent Bacterial vaginosis (BV) and STIs through hygienic period practices, and may help them avoid bad practices in an attempt to maintain vaginal dryness. The goal of this interventional trial is to test the impact of menstrual cups on vaginal microbiome, BV, and STIs of poor women at high risk for STIs and HIV. We predict to see 25% less BV, our primary outcome, over one year. This trial aims to learn more about the safety of the intervention, and understand what is needed to fully implement the program.

NCT ID: NCT05652959 Completed - Bacterial Vaginosis Clinical Trials

Real-world Performance and Safety of Cerviron® in the Treatment of Vaginitis

Start date: May 20, 2021
Phase:
Study type: Observational

Vaginitis is a broad term that includes a range of gynecological disorders characterized by infection of vaginal mucosa, inflammation of vulva and alteration of the normal vaginal microflora. The most prevalent is bacterial vaginosis, followed by other clinical entities such as candidiasis, trichomoniasis and non-specific vaginitis. A collection of clinical data was conducted to assess the tolerability of Cerviron® ovules in the treatment and management of various types of vaginitis in clinical practice. A total of 111 women aged between 20 and 70 years were recruited, 71 of whom were treated with Cerviron® ovules as monotherapy and 40 who used Cerviron® ovules as supportive treatment in conjunction with antibiotic therapy. The aim of our study was to assess the relief in vaginal symptoms and changes in the normal vaginal pH level after 3 months of treatment with Cerviron® medical device in real-life clinical practice settings.

NCT ID: NCT05587283 Recruiting - Clinical trials for Bacterial Infections

Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Women

Start date: November 2, 2022
Phase: Phase 1
Study type: Interventional

This is a phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled, dose escalation, clinical trial enrolling 24 healthy participants. The main subject is to investigate the safety and tolerability of the LABTHERA-001 capsule and to explore the acceptability of the capsule.

NCT ID: NCT05557318 Recruiting - Vaginitis Clinical Trials

Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge

Start date: October 8, 2022
Phase: N/A
Study type: Interventional

This clinical study aims to train the algorithm and assess the performance of the Ainos Flora Women's Vaginal Health Tester in identifying vaginal infections.

NCT ID: NCT05432154 Completed - Atrophic Vaginitis Clinical Trials

An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients

NCT ID: NCT05396261 Completed - Vaginitis Clinical Trials

a Flexible Wound Dressing for the Management of Genital Skin Conditions

Start date: January 31, 2018
Phase: N/A
Study type: Interventional

The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients

NCT ID: NCT05383521 Not yet recruiting - Clinical trials for Trichomonas Vaginitis

Safety and Efficacy of Two Oral Tinidazole Regimens for Refractory Trichomonas Vaginitis

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

We compare two oral tinidazole regimens for refractory trichomonas vaginitis.

NCT ID: NCT05340790 Recruiting - Bacterial Vaginosis Clinical Trials

First in Human Study in Healthy Volunteers of Antimicrobial Peptide PL-18 Vaginal Suppositories

Start date: August 1, 2022
Phase: Phase 1
Study type: Interventional

This is a Single-center, Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate the Safety, Tolerability and PK Profiles of Single and Multiple Ascending Doses of Antimicrobial Peptide PL-18 Vaginal Suppositories.