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 adults with advanced solid tumors that are antigen-rich. This open-label, multicenter Phase 1/2 study aims to assess the safety, tolerability, and preliminary clinical activity of STAR0602 in participants with unresectable, locally advanced, or metastatic solid tumors where standard therapies are not effective or suitable. The study has two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1, STAR0602 is given intravenously to determine safety, the maximum tolerated dose, and the recommended dose for Phase 2. In Phase 2, participants receive STAR0602 at the established recommended dose to further evaluate safety and clinical activity. Clinical activity is measured by tumor response rates, duration of response, disease control, and progression-free survival. Participants will receive STAR0602 infusions in cycles lasting 28 days. Researchers will monitor safety by tracking dose-limiting toxicities, adverse events, and serious adverse events for up to three years. Tumor responses and survival outcomes are also assessed over this period. Pharmacokinetic measures and anti-drug antibody formation will be evaluated at specified cycles. The total study duration and follow-up can extend up to three years to gather comprehensive safety and activity data.

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 tablets—1400 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 mg—and 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 intervention's impact.

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 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.

Researchers are evaluating the clinical cure rate and safety of a specialized Vaginal Cooling Device (VCD) in women with uncomplicated vulvovaginal candidiasis (VVC), a yeast infection affecting the vagina. The study also aims to assess the safety, fungal cure rates, speed and effectiveness of symptom relief, vaginal hyphae and immune cell counts, as well as quality-of-life measures related to VVC. Participants will use the vaginal cooling device, which is a medical-grade polymer capsule filled with inert fluid, twice daily for 30 minutes each time over three days, totaling 3 hours of use. This open-label, uncontrolled study involves women aged 22 to 49 who have confirmed VVC. There is no placebo or comparison group, and the device use is monitored to evaluate its effects. Women in the study will undergo clinical diagnosis and confirmation of VVC by laboratory tests at baseline. Researchers will monitor the number of clinical cures at 7 days, with follow-up at 28 days to assess ongoing cure rates. Participants will avoid vaginal sexual activity during the study and use a smartphone app to support study procedures. Safety, symptom resolution, and quality-of-life changes will be closely tracked throughout the study period, which concludes by June 2026.

Researchers are evaluating the safety and effectiveness of Multi-Gyn FemiTotal, a vaginal gel, for treating and preventing bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) in women. This study includes 40 women with VVC itching symptoms and 49 women with BV confirmed by Amsel criteria. The main goal is to assess how well the gel relieves itching and treats BV and VVC symptoms 21 days after starting treatment. Participants will use the Multi-Gyn FemiTotal vaginal gel for 7 days during the treatment phase. If symptoms are considered cured 21 days after treatment begins, they will enter a prevention phase with follow-up visits up to 4 months after starting treatment to monitor for any recurrence of BV or VVC. This is a single-arm, multicenter clinical investigation. During the study, participants will be assessed by doctors and complete questionnaires to evaluate symptom relief and treatment effectiveness at 21 days. Follow-up evaluations at 4 months will check for the prevention of BV and VVC recurrence. Participants will also be monitored for safety and adherence to the treatment and follow-up schedule. The total study duration for each participant includes treatment and extended follow-up for up to 4 months.