Vaginitis

The trial investigates vaginal dysbiosis in premenopausal women with elevated vaginal pH, aiming to see if a non-hormonal topical product can improve vaginal microbiota and help prevent future infections. The study includes women aged 18 to 45 with regular menstrual cycles and examines both symptomatic and asymptomatic cases of dysbiosis. The research is conducted as a multicenter, open, comparative study with random assignment to groups, sponsored by Procare Health Iberia S.L. Participants are divided into three groups symptomatic women receiving Palomacareae vaginal gel for 6 days, asymptomatic women receiving the same treatment for 6 days, and asymptomatic women under monitored follow-up without treatment. The study involves two visits an initial visit between days 9 and 15 of the menstrual cycle and a final visit within 5 days after treatment or equivalent timing for the monitoring group. The trial consists of a pilot phase with 30 patients and an extension phase adding 60 more, totaling 90 participants. During the approximately 11-12 day study period, researchers will assess the effect of Palomacareae vaginal gel on vaginal microbiota, symptoms, vaginal pH, user satisfaction, and safety. Evaluations include diagnostic tests and symptom monitoring at both visits. Participants will be closely followed for tolerability and response to treatment, with outcomes measured by vaginal microbiota changes and symptom improvement recorded through the study duration.

Researchers are evaluating whether taking oral Probiotics called Umeta-mimi for 30 days combined with using Metronidazole vaginal suppositories for 7 days is better at preventing the return of bacterial vaginosis BV than using Metronidazole vaginal suppositories alone. This study also aims to understand how vaginal and intestinal bacteria relate by examining samples at several points during and after treatment. The study is a Phase 4, randomized controlled trial focused on women with BV. Participants are divided into two groups one receives Metronidazole vaginal suppositories 200 mg, two capsules daily for 7 days alone, and the other receives the same suppositories plus oral Probiotics Umeta-mimi, 5 billion colony-forming units daily for 30 days. The study collects vaginal and fecal samples at baseline, 14 days after treatment, one month after treatment, and after the third and sixth menstrual cycles following treatment to analyze bacterial changes. During the study, women will attend visits for sample collection and evaluation of bacterial vaginosis status at specified times. Researchers measure the cure rate of BV 14 days after treatment and monitor recurrence up to the sixth menstruation after treatment. The total observation period extends through multiple menstrual cycles to assess long-term effects, with ongoing monitoring of vaginal and fecal microbiota.

Researchers are evaluating STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in participants with advanced solid tumors that have high antigen levels. This open-label, multicenter Phase 12 study aims to assess the safety, tolerability, and early clinical activity of STAR0602 given alone and in combination with chemotherapy for these tumors, which have limited effective standard treatments. The trial includes participants with unresectable, locally advanced, or metastatic solid tumors, including specific subtypes like NSCLC and colorectal cancer. The study has two parts Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1, STAR0602 is given intravenously to determine the maximum tolerated dose and safety profile. Phase 2 uses the recommended dose from Phase 1 to further evaluate safety and preliminary effectiveness, measuring tumor responses and disease control. Chemotherapy drugs like Irinotecan and Docetaxel may be combined with STAR0602, and treatments are administered by infusion following defined cycles. Participants will undergo multiple assessments including safety monitoring for adverse events and serious adverse events up to three years. Researchers will measure tumor response rates, duration of response, disease control rate, progression-free survival, and other pharmacokinetic parameters. Study visits will include treatment administration, laboratory tests, and evaluations to track the therapys effects and tolerability over time. The total participation period may extend up to three years for follow-up and monitoring.

Researchers are evaluating the effectiveness and safety of an investigational drug called WXSH0102 compared to the active drug fluconazole for treating vulvovaginal candidiasis VVC. This multicenter, randomized, double-blind, active-controlled, dose-ranging Phase II clinical trial involves female patients aged 18 to 64 years who have been diagnosed with VVC. The study aims to determine which dosing regimen of WXSH0102 might best treat this condition by comparing it with fluconazole, a standard treatment. Participants are randomly assigned to one of four groups three groups receive different doses of WXSH0102 tablets1400 mg on the first day followed by 700 mg on days 2 and 3 1000 mg followed by 500 mg or 600 mg followed by 300 mgand the fourth group receives a single dose of fluconazole capsules on day 1. All medications are given orally during a treatment period lasting three days. The study consists of three phases screening and enrollment before treatment, the treatment period from day 1 to day 3, and a follow-up period with visits on days 4, 11 plus or minus 2 days, and 25 plus or minus 3 days. During the study, participants will be assessed for cure rates, clinical improvement, and clearance of the fungal infection at follow-up visits, particularly on day 11 and day 25. Researchers will also monitor vaginal health, adverse events, and drug concentration levels in the body. Participants agree to avoid sexual activity and use condoms throughout the study. The total study duration includes screening, treatment, and follow-up visits over approximately 25 days from the first treatment dose.

Researchers are studying sexual health and vulvovaginal health in premenopausal and perimenopausal women with hormone receptor positive breast cancer who are receiving ovarian suppression. The study aims to find out if starting sexual health counseling and using non-hormonal moisturizers early can prevent or reduce side effects like vaginal dryness and sexual dysfunction. This is compared to the usual care approach where treatment begins only after symptoms appear. Participants will be randomly assigned to one of two groups. One group will receive sexual health counseling and start using non-hormonal moisturizers 3 to 5 times weekly from the beginning of ovarian suppression, along with education about vaginal dilators and a consultation with a pelvic floor physical therapist. The other group will start treatment only after developing symptoms and will receive a list of recommended moisturizers to purchase themselves. Both groups will complete various questionnaires to monitor sexual health and vaginal symptoms. During the study, participants will be monitored through surveys and subjective and objective assessments of vaginal dryness and sexual function. Researchers will track the number of participants who have a score of 4 or higher on the Vaginal Assessment Scale within one year. The study includes regular completion of validated questionnaires and a weekly diary about moisturizer use. The total participation time corresponds with one year of follow-up to evaluate the interventions impact.

Researchers are evaluating the safety, tolerability, and effectiveness of OCF001 intravaginal gel in women aged 18 to 65 who have acute vulvovaginal candidiasis, a fungal infection of the vagina. This randomized, double-blind, placebo-controlled Phase 2a study aims to assess how well this new antifungal treatment works and how safely it can be used. Women with moderate to severe symptoms and signs of infection confirmed by specific microscopic tests are eligible to participate. Participants will be randomly assigned to receive either 5 grams of OCF001 vaginal gel or a placebo gel once daily for 7 days. The OCF001 gel contains an antifungal antibiotic formulated in a water-friendly gel. The study compares the effects of the active drug against a placebo to evaluate clinical cure after the treatment period. The main treatment phase lasts 7 days, with safety and tolerability monitored over 4 weeks. During the study, participants will be monitored through clinical assessments including vaginal examinations and laboratory tests to confirm infection and evaluate treatment effects. Researchers will track symptoms, signs of infection, and any side effects. Tests such as potassium hydroxide wet mounts and vaginal pH measurements will be used. Follow-up visits will assess clinical cure and local tolerability. The total participation time includes treatment and a 4-week safety evaluation. Participants must comply with study schedules and contraception requirements during the trial.

Researchers are studying the management of Genitourinary Syndrome of Menopause GSM, a condition causing symptoms like vaginal atrophy that affects quality of life in postmenopausal women. This trial aims to assess the safety and effects of a new hormone-free gel called XCMIM20m applied topically to the vulvovaginal area. The study uses a patient-reported outcome measure called the Day-to-Day Impact of Vaginal Aging DIVA questionnaire to compare symptoms before and after treatment. Participants will apply 2 ml of the XCMIM20m gel daily, divided into two 1 ml doses taken about 12 hours apart, preferably morning and bedtime, for 8 weeks. The gel is manually applied to the vulvar area, including the vaginal opening, without an intravaginal applicator. Adverse effects like irritation or infections will be monitored and recorded throughout the study. Women will self-assess their symptoms using the DIVA questionnaire at the start and end of the 8-week treatment to evaluate changes in GSM symptoms and quality of life. Researchers will track any side effects and collect detailed information if any occur. The primary measurement is the change in symptom impact on quality of life after 8 weeks of using the gel, with additional focus on the most affected quality of life areas.

This research aims to evaluate how treatment with FB301 affects the balance of vaginal bacteria in women aged 18 to 45 who have bacterial vaginosis. The study compares the effects of FB301 alone or combined with pre-treatment using either a vaginal antiseptic wash chlorhexidine, an oral antibiotic metronidazole, or both. The main focus is on changes in key vaginal bacteria, Lactobacillus crispatus and Lactobacillus jensenii, over a 10-week period after treatment. Participants are randomly assigned to one of four groups Group 1 receives FB301 with metronidazole for 15 days followed by FB301 alone in the next menstrual cycle Group 2 receives a vaginal cleanse with chlorhexidine before FB301 treatment and then FB301 alone in the next cycle Group 3 receives chlorhexidine, metronidazole, and FB301, followed by a second chlorhexidine cleanse and FB301 Group 4 receives only FB301 throughout. Treatments are given over two consecutive menstrual cycles with specific dosing schedules detailed for each group. Throughout the study, participants attend up to six visits at the study center. They provide vaginal swabs and vaginal secretion samples using a menstrual disc at several visits, and blood samples at up to six visits. Researchers monitor changes in the vaginal microbiome, safety, and tolerability of FB301 with or without pre-treatment. The primary outcome measures focus on the relative abundance of Lactobacillus species from baseline to week 3 and through week 10. Participation lasts across the two treatment cycles and follow-up assessments.

This trial focuses on women aged 25 to 45 with high-grade cervical intraepithelial lesions CIN 3 caused by high-risk HPV. Researchers aim to understand the local immune response, cervicovaginal environment, and microbiological profiles in these patients when treated with the immunomodulator imiquimod. The study compares the immune effects of imiquimod to the standard Loop Electrosurgical Excision Procedure LEEP, also including a healthy group for comparison. Participants are divided into three groups one group receives 16 doses of imiquimod applied to the cervix twice a week followed by LEEP the second undergoes standard LEEP treatment alone the third group consists of healthy women with negative cytology and HPV tests. Blood and cervicovaginal samples are collected at multiple times for immunophenotyping, immune mediator analysis, and microbiome evaluation. Throughout the study, researchers monitor immune responses and lesion changes by analyzing histological samples and immune markers during and after treatment. The main outcome is the number of patients showing histological regression of high-grade lesions over three years. The study also investigates correlations between vaginal microbiome changes and immune responses, with all participants followed for up to three years to assess these outcomes and safety.

Researchers are evaluating the Cern Device, an intravaginal tool using low level visible light combined with a natural photosensitizer, to treat bacterial vaginosis and fungal vaginitis in premenopausal women. This trial aims to determine if the device can resolve symptoms and produce negative diagnostic tests after treatment, while also monitoring safety and any medical problems participants may experience. Participants are assigned to one of two groups based on their condition. Those with bacterial vaginosis receive 30 minutes of daily treatment with the Cern Device for 5 consecutive days, while those with fungal vaginitis receive 60 minutes of daily treatment for 5 days. After treatment, participants enter a 45-day follow-up period including daily teleconference check-ins during treatment, weekly follow-ups, and a final assessment 28 days post-treatment. During the study, participants keep a daily diary and attend clinic visits for evaluations. Researchers assess symptom resolution, diagnostic test results, and safety by monitoring adverse events and clinical exams. Treatment adherence and tolerance are tracked through telecom follow-ups and self-reporting. The entire participation lasts through treatment and the 45-day observation period to gather comprehensive data on effectiveness and safety.