Clinical Trials for Vaginitis

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Vaginitis from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 15
• Active, not recruiting: 5
• Completed: 17
• Other: 13

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT01829204 — Prospective Data Bank Creation to Study Vaginal Conditions

The purpose of this study is to identify and elucidate the pattern and perhaps role of atypical proteins, cytokines and vaginal microbial flora in the pathogenic mechanisms involved in the development of vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor.

NCT04046900 — Vaginal Microbiota Transplant

This is a randomized trial of vaginal microbiome transplant vs. saline placebo to restore a Lactobacillus dominant vaginal microbial community in women with recurrent bacterial vaginosis.

NCT05953090 — VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term safety and efficacy of the device.

NCT05753813 — Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome

This project aims to investigate if the contraceptive method, Phexxi, causes changes to the composition of the vaginal microbiome. The investigators hypothesize that regular use of Phexxi will cause increased colonization of lactic acid-producing lactobacilli, which could have positive effects in the way of preventing recurrent episodes of BV and candida infections.

NCT06070454 — Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions

Primary:

• To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision
• To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease We will use a vulvovaginal swab to test for the most common causes of vulvovagin…

NCT06261840 — Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole

This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ) and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both women and men.

NCT06983041 — Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)

The objective of this study is to determine clinical cure rate and safety of a proprietary Vaginal Cooling Device (VCD) in women with VCC. In addition, the safety, mycological cure rates, the speed and efficacy of symptom resolution, vaginal hyphae and polymorphonuclear (PMN) scores, and Quality-of-Life (QoL) parameters will be determined.

NCT07109869 — Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis

This is a Phase 3 clinical study to evaluate the efficacy, safety, and tolerability of boric acid 600 mg vaginal inserts in patients with VVC.

NCT07346287 — ASSIST-VLA: Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy

Vaginal atrophy patients receiving vaginal laser therapy will be treated with daily 7-0940® following a laser session to evaluate the safety and efficacy of the product as an adjunct treatment. Clinical outcomes will be assessed using validated investigator- and patient-reported measures, with safety and symptom progression monitored throughout the study.

NCT07234786 — Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections

The goal of this clinical trial is to assess the safety and efficacy of Multi-Gyn Femitotal to treat and prevent women suffering from bacterial vaginosis and vulvo vaginal candidiasis. 40 subjects with itching symptoms of VVC and 49 subjects with BV as confirmed using Amsel criteria will be included and will use the device for 7 days (treatment phase). If the VVC symptoms and BV are considered …

NCT07153276 — TREATMENT OF VAGINAL DRYNESS IN SJÖGREN’S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE

Sjögren’s disease (SjD) is a chronic, immune-mediated, systemic inflammatory disease characterized mainly by involvement of the salivary and lacrimal glands, causing symptoms of sicca syndrome. The disease predominantly affects women (9:1 to 20:1), with a peak incidence between 40 and 60 years of age. Symptoms of dryness include those resulting from vaginitis sicca, such as vulvovaginal irritat…

NCT07199998 — Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota

The availability, effectiveness, and safety of menstrual protection represent a key public health issue. However, research on women’s menstrual and sexual health remains extremely limited. Whether societal or pathological, many hypotheses are emerging regarding the effects of menstrual protection products, yet little attention has been given to the products themselves, their societal role, or t…

NCT05434104 — The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study

Three-quarters of women have bacterial vaginosis (BV) or vaginal thrush/candida yeast infection at least once during their lifetime. Symptoms can include abnormal vaginal discharge, soreness, itching and an unpleasant smell. BV during pregnancy can make the baby come too early. In the UK over a million women suffer recurrent vaginal infections. These can affect their sexual relationships and qu…

NCT07603895 — Evaluation of the Efficacy of a Probiotic Product as an Adjuvant Treatment for Vulvovaginal Candidiasis

Open-label, randomized clinical trial with a control group and a 4-week intervention period. The study will evaluate the efficacy of the probiotic supplement Bioithas WOMAN® as an adjunctive treatment in women with clinically suspected vulvovaginal candidiasis (VVC).

All participants will receive the antifungal treatment prescribed by the investigator. Participants allocated to the probiotic g…

NCT07521137 — Biweekly Long-term Occidiofungin Study for Suppression of Mycotic Recurrence

A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of OCF001 Intravaginal Gel in Women with Acute Vulvovaginal Candidiasis

Active, Not Recruiting

NCT04930107 — Vulvovaginal Candidiasis in Canadian Females

Vulvovaginal candidiasis (VVC; colloquially referred to as a ‘yeast infection’) is a prevalent mucosal infection caused by Candida spp. that affects ~75% of women at least once in their life. VVC usually responds well to treatment, yet a small but significant fraction of women experience recurrent yeast infections even with weekly treatment. A further complication in understanding the causes o…

NCT05666778 — Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs

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 w…

NCT06190509 — Assessing the Safety, Immune Response, and Early Efficacy of a Candida Vaccine in Women With Recurrent Vulvovaginal Candidiasis: A Randomized Controlled Study

In this study, the pentavalent bioconjugate candidate vaccine (Candi5V) against Candida will be tested to obtain first-time-in-human (FTIH) data on its safety, immunogenicity, and preliminary efficacy in women with recurrent vulvovaginal candidiasis.

NCT05977491 — Point-of-care Tests for Vaginal Discharge in Nepal

The goal of this clinical trial is to examine if and how the implementation of point-of care-tests (POCT) for sexually transmitted infections in the management of abnormal vaginal discharge reduces the overtreatment with antibiotics in a low income country. The setting is a university hospital in a semi-rural area in Nepal and several of its rural out-reach-centers. The plan is to include 1500 …

NCT07405853 — An Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Vulvovaginal Candidiasis Compared With an Untreated Control Group

The goal of this clinical trial is to learn if pHyph works to reduce signs and symptoms of vulvovaginal candidiasis (thrush). It will also learn about the safety of pHyph. The main questions it aims to answer are:

• Does pHyph reduce the signs and symptoms of vulvovaginal candidiasis after an initial 6 day daily treatment?
• Does an additional 6 day treatment course after the initial one furth…

Not Yet Recruiting

NCT07302035 — A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women

This is a Phase Ia single-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, Pharmacokinetic of GenSci142 in Chinese healthy women.

NCT07344064 — The Effects of Adjunctive Therapy With Vaginal Tablets Lactobacillus Acidophilus and a Low Dose Estriol (Gynoflor®) to Prolong Pregnancy Time in Preterm Labor, A Randomized Controlled Trial

The study aim to study The Adjunctive therapy with vaginal tablets containing Lactobacillus acidophilus KS400 and low-dose Estriol (Gynoflor®) in addition to standard tocolytic treatment administered once daily for 6 days starting the same day as tocolytic therapy, in pregnant women diagnosed with preterm labor at gestational age 24-33 weeks .Primary Outcome is the rate of pregnancy prolongatio…

NCT07492654 — Clinical Study on the Prevention and Treatment of Radiation Vaginitis With Triethanolamine Cream

The objective of this clinical trial is to understand whether triethanolamine cream can prevent and treat acute radiation vaginitis. It will also learn about the safety of triethanolamine cream. The main questions it aims to answer include:

Can triethanolamine cream reduce the incidence and severity of radiation vaginitis in cervical cancer patients undergoing radiotherapy?

What medical probl…

NCT07481955 — Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial

The goal of this study is to evaluate how treatment with FB301 affects the balance of vaginal bacteria in women (aged 18-45) with bacterial vaginosis after pre-treatment with either a vaginal antiseptic wash (chlorhexidine), an oral antibiotic (metronidazole), or both.

The main question it aims to answer is:

Does treatment with FB301, with or without pre-treatment using a vaginal antiseptic (…

NCT07474831 — Evaluation of the Ability of Lactobacillus Crispatus CRP21 to Reduce the Incidence of Recurrent Bacterial Vaginosis

Recurrent bacterial vaginosis is a common condition in women of reproductive age and is characterized by a disruption of the normal vaginal microbiota, with a reduction in Lactobacillus species and an overgrowth of anaerobic bacteria such as Gardnerella vaginalis. Recurrence rates after standard antibiotic treatment are high. Lactobacillus crispatus is considered one of the most protective spec…

NCT07527572 — Study to Evaluate Efficacy and Safety of Gyntima® Balance in Preventing Recurrences of Bacterial Vaginosis

The vagina is a dynamic muscular organ whose health relies on a Lactobacillus-dominant microbiota that maintains low pH and protects against infections. Bacterial vaginosis (BV) is the most common vaginal imbalance in women of reproductive age, caused by depletion of protective Lactobacillus species and overgrowth of anaerobic bacteria such as Gardnerella vaginalis. BV affects an estimated 23-2…

NCT07483671 — Efficacy and Safety Study of BPR-101 Capsules in Combination With Metronidazole in BV Patients

This trial employed a multicenter, randomized, double-blind, parallel, placebo-controlled design to evaluate the preventive effect of BPR-101 capsules combined with metronidazole on the recurrence of BV, as well as the cure rate and safety.

NCT07290439 — Improving Maternal and Child Health Through Point-of-care STI Testing

The goal of this clinical trial is to learn if point-of-care tests (POCTs) for sexually transmitted infections (STIs) improve the timely treatment of syphilis, chlamydia, gonorrhea, and trichomonas in pregnant women. It will also learn about the feasibility, acceptability, and cost-effectiveness of implementing POCTs in a large safety-net hospital setting.

The main questions it aims to answer …

NCT07607470 — Large Algorithm Setting and Validation Study

In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay.

The Nanopath assay is an amplification-free molecular test that detects pathogens …

NCT07526948 — Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV

This is a research study about the effects of vaginal estradiol compared to moisturizer on vaginal symptoms of menopause and the microbiome in women with HIV. This research study aims to understand how vaginal products affect the aging of the female genital tract in women living with HIV who are menopausal or perimenopausal and have vaginal or urinary symptoms. There is a comparison group of wo…

NCT07663838 — A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)

A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial vaginosis (BV).

NCT07566754 — MOTIF@FRESH: Modifying Organisms Transvaginally in Females @ FRESH

The MOTIF@ FRESH trial will assess the safety and efficacy of “vaginal microbiome transplantation” (VMT). Healthy females will be enrolled to donate vaginal fluid which will be processed and transplanted in females with a history of recurrent bacterial vaginosis (BV), treated with antibiotics.

Enrolling by Invitation

NCT07305844 — Impact of Clinician-administered Vaginal Live Biotherapeutic Product

This is an open-label, single-arm, Phase Ib trial assessing the consistency of response and colonization kinetics of a vaginally inserted live biotherapeutic intervention with optimized adherence.

Completed Trials

NCT00984399 — Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen

The purpose of this study is to see if Vagifem® 10mcg is safe for women who have had breast cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the vagina. It relieves vaginal dryness. Women who have had breast cancer are usually told not to take estrogen. This is because estrogen use can lead to a breast cancer recurrence or a new primary breast cancer. It is uncl…

NCT01722708 — Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies

Abnormal vaginal flora is a risk factor for preterm labor. Therefore, in high risk pregnancies for preterm labor the diagnosis and treatment of abnormal flora is indicated. Clindamycin and metronidazole given orally are both acceptable treatments in these cases. The purpose of this study is to compare the effectiveness of Clindamycin Vs metronidazole for the treatment of abnormal vaginal flora …

NCT03562156 — A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)

Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for RVVC than other oral anti-fungal medicines.

This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for …

NCT03561701 — A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)

Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for RVVC than other oral antifungal medicines.

This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for t…

NCT03681678 — Laser Therapy for Treatment of Urogenital Symptoms in Women

This is a prospective observational study of women undergoing vaginal treatment with the fractional carbon dioxide (fCO2) laser for various urogenital symptoms.

NCT03532464 — Azithromycin Compared With Doxycycline for Treating Anorectal Chlamydia Trachomatis Infection Concomitant to a Vaginal Infection

Chlamydia trachomatis is the most commonly reported bacterial sexually transmitted infection (STI), especially among young women. Up to 75% of C. trachomatis infected women are asymptomatic. If untreated, C. trachomatis infection can cause sequelae such as pelvic inflammatory disease, ectopic pregnancy and tubal factor infertility. C. trachomatis can also cause anorectal infections, which are t…

NCT07418996 — Live Double Combined Lactobacillus Capsule for Vaginal Use（IIa）

This is a mutilcenter, randomized, double-blind, Metronidazole controlled phase lIa clinical study to evaluate the safety and tolerability of dual - live lactobacilli-containing vaginal capsules for the treatment of Bacterial Vaginosis.

NCT05058313 — Evaluation of the Safety and Performance of the MILTA GYNECO Vaginal Probe in Postmenopausal Women With Vaginal Atrophy

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 hormon…

NCT07241871 — Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis

The aim of this study is to find out how well the medical device Lactal Gel works and how safe it is. The product will be used to treat bacterial vaginosis in a group of fifty women aged 18 years or older.

All participants will receive the one-week treatment as part of their usual medical care.

Each participant will have two visits: one at the beginning of the study (the initial assessment) a…

NCT07418918 — Live Double Combined Lactobacillus Capsule for Vaginal Use(IIb)

This is a multicenter, randomized, double-blind, placebo-controlled phase IIb clinical study, to evaluate the efficacy and safety of the dual - live Lactobacilli-containing vaginal capsule for the treatment of bacterial vaginosis.

NCT07247851 — Title of the Protocol: Combined Use of Vaginal Clindamycin Cream and Oral Metronidazole Versus Oral Metronidazole

Bacterial vaginosis (BV) constitutes a gynecological condition characterized by an alteration of the vaginal microenvironment and more specifically an alteration of the normal Lactobacillus-dominated vaginal flora, to a flora that includes a variety of facultative and obligatory anaerobic bacteria; this alteration causes offensive smelling vaginal discharge, leading to significant psychological…

NCT06228469 — Cytolytic Vaginosis Multicentre Registry

The goal of this registry is to learn more about cytolytic vaginosis, a little known and controversial condition. The main questions the registry aims to answer are:

• What are risk factors of cytolytic vaginosis?
• Are there defining symptoms of cytolytic vaginosis?
• What features on wet mount should be used to diagnosis cytolytic vaginosis?
• Are baking soda vaginal irrigations an effective…

NCT06474247 — Postbiotic as Adjunct Treatment for Vaginal Candidiasis

This project aims to study the efficacy of oral administration of postbiotic at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks compared to placebo.

NCT07418957 — Efficacy and Safety of Vaginal Lactobacillus Dual Probiotic Capsules in Bacterial Vaginosis

Primary Objective: To confirm that the clinical cure rate of Vaginal Lactobacillus Dual Probiotic Capsules for bacterial vaginosis (BV) is superior to placebo at the 21-30 day post-treatment visit (Day 21 to Day 30).

Key Secondary Objective: To compare the clinical cure rate of Vaginal Lactobacillus Dual Probiotic Capsules versus placebo for BV at the 15-18 day post-treatment visit (Day 15 to …

NCT06438575 — Point of Care Diagnosis of Vaginal Infections

Vaginal infections are a common gynecologic issue and may cause significant symptoms and discomfort for individuals. Point of care tests are used to diagnose infections in the office, with an advantage of quick diagnosis and treatment. Examples of point of care tests are urine pregnancy, rapid strep and COVID-19 tests. This study will enroll persons with vaginal complaints and compare diagnosis…

NCT06985433 — Light Treatment of Vaginal Infections in Reproductive Age Women

Antimicrobials have helped in managing vaginal dysbiotic conditions such as bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC). However, their increasing inefficiency and rise in antimicrobial resistance (AMR) is a challenge and threat to public health. Therefore, this study will investigate the safety and efficacy of light as an antimicrobial to treat vulvovaginal infections.

NCT07394777 — An Open Single-armed Investigation to Evaluate the Safety of pHyph Following a Prolonged Treatment Duration in Adult Women With Bacterial Vaginosis

1. Rationale Bacterial vaginosis (BV) is caused by an overgrowth of bacteria and affects most women at some point. The infections can cause foul-smelling discharge and sometimes itching and burning. There are already some approved medications for the treatment of BV. They are not always effective, which means that the infection often returns. Many of these treatments contain antibiotics. In thi…