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Vaginitis clinical trials

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NCT ID: NCT06056947 Completed - Bacterial Vaginosis Clinical Trials

Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule

One-Shot
Start date: July 20, 2020
Phase: Phase 3
Study type: Interventional

Efficacy and safety of two new formulations compared to Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections was evaluated in this randomized, three-arms, multicentral study.

NCT ID: NCT05882851 Completed - Vaginitis Clinical Trials

Effect of Nutrition in the Treatment of Vaginitis

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

Vaginitis is an inflammation or infection of the vagina. It is successfully treated for causative pathogenesis. However, it can be recurrent or treatment-resistant vaginitis. The investigator's aim in this study is to investigate the effect of nutrition and risk factors on the failure of vaginitis treatment.

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: 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: 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: NCT05058313 Completed - Clinical trials for Urinary Incontinence

Evaluation of the Safety and Performance of the MILTA GYNECO Vaginal Probe in Postmenopausal Women With Vaginal Atrophy

SIVAM
Start date: March 29, 2022
Phase: N/A
Study type: Interventional

Vulvovaginal atrophy is common after menopause, with a significant negative effect on quality of life. Large cohort studies have reported the prevalence of vaginal dryness to be between 27% and 55% and dyspareunia between 32% and 41%. Management of urogenital atrophy includes lifestyle modification, nonhormonal treatments (vaginal lubricants or moisturizers, laser treatments), as well as hormonal treatments. The disadvantages of the non-surgical methods are average results, discontinuation, and frequent contraindications to hormonal treatments.This has led to a strong interest in the development of non-invasive or minimally invasive methods that are easy to implement, effective and durable. Photobiomodulation therapy (PBMT) has been proposed as an alternative for the treatment of genitourinary menopausal syndrome (GMS) and stress urinary incontinence. PBMT devices exert their effect via non-thermal mechanisms. PBMT stimulates collagen and elastin synthesis in the vaginal tissue, to support the urethrovaginal sphincter and urethra, and to promote vasodilation in the vaginal and urethral submucosa. PHYSIOQUANTA has developed a vaginal probe coupled with its innovative MILTA™ process synergistically combining NPCL (Nano-Pulsed Cold Laser) laser emitters, infrared diodes and RGB (Red Green Blue) diodes, operating in a magnetic tunnel. The MILTA acts deeper than LEDs, due to the diffusion of photons in soft tissues. In this study, the study investigators aimed to evaluate the safety and performance of the MILTA™ GYNECO vaginal probe in a pilot study of first use in women. This clinical study on the MILTA vaginal probe is expected to result in its CE marking Class IIb DM.

NCT ID: NCT04735705 Completed - Clinical trials for Vaginitis and Vulvovaginitis

Clinical Investigation To Evaluate Cerviron Ovules® in Symptomatic Vaginitis

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

CYRON is a Prospective, Open-Label, Pilot, Multicentric Clinical Investigation to Evaluate the Performance and Safety of Cerviron Ovules® in the Local Treatment of Non-Specific or Endogenous, Symptomatic Vaginitis. The primary objective is to assess the therapeutic performance and tolerability of Cerviron® Ovules in patients with symptomatic, non-specific, non-infectious vaginitis, and endogenous symptomatic infections. The secondary objective of this clinical investigation is the assessment of performance of the medical device by several additionally clinical outcomes (vaginal discharge, vaginal pH, microscopic characteristics of inflammatory cells and characteristics of vaginal microflora). Participants will also evaluate the degree of satisfaction related to the use of the medical device.

NCT ID: NCT04676503 Completed - Vaginitis Clinical Trials

Vaginal and Rectal Colonization of Lactobacillus Crispatus NTCVAG04 Following Oral Administration in Patients With History of Vaginitis/Vaginosis

Start date: November 22, 2019
Phase: N/A
Study type: Interventional

The 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.