Loading clinical trials...
Loading clinical trials...
Showing 1-4 of 4 trials
NCT06922136
Eligible patients will be randomized to treatment with Hyalo Gyn® gel or placebo, at the dose regimen of 1 application deeply in the vagina every 3 days (i.e. an application is followed by 2 days without application), up to a total of 12 consecutive weeks. After 12 weeks (i.e. at Visit 3), the following rules will apply for the second 12- week phase of the study: * In case of resolution of the symptom (the dryness single score is equal to zero), the patient will suspend treatment and will undergo follow-up visits; * In case of the single score is reduced but still greater than zero: the subject will receive Hyalo Gyn® open-label. * In case the dryness gets worse the subject can choose whether receive Hyalo Gyn® gel open-label or undergo the follow-up visits. Patients will be allowed to use only water-based lubricants, not containing HA, hormones, or isoflavones, if necessary, only when engaging in sexual activity and specifying the reason for its use (multiple choice answer). The number of lubricant applications, as well as the frequency of the sexual activity, will be recorded weekly in the diary by the patient.
NCT07367061
Clinical investigation to assess safety and efficacy of INNEA AQUA in adult women with Vulvo-Vaginal Atrophy (VVA). To assess the Safety and efficacy of INNEA AQUA
NCT07306611
Vulvovaginal health is a key aspect of active and healthy aging for all women. Hormonal deprivation that occurs during menopause significantly affects the anatomy and function of urogenital tissues, leading to their atrophy. Vaginal creams and suppositories containing estrogens are the standard treatment and can improve this condition. However, they require continuous application, which often makes adherence to treatment challenging. Additionally, women with hormone-dependent tumors, such as most breast cancers and many gynecological cancers, are even more affected by this issue. These women are often treated with anti-estrogen medications, undergo radio or chemotherapy, and are frequently younger, with the added complication that the standard treatment is contraindicated for them. To address this important issue, the study titled "Regenerative Treatment of Female Genital Atrophy" was developed. If you meet the required criteria, we would like to invite you to participate. Inclusion Criteria: * Clinical complaints of genital atrophy (e.g., dryness, burning, itching, discomfort, or pain during intercourse). * Contraindication to standard local hormonal treatment (e.g., allergy, bothersome side effects, lack of improvement with standard treatment, history of hormone-dependent cancer, or thrombotic event treated at least two years ago). This study focuses on Regenerative Medicine, which aims to support the regeneration of cells, tissues, or organs in the human body to restore normal function. This field holds significant curative and preventive potential. The selected regenerative treatment, widely used in various medical fields (such as dentistry and orthopedics), is derived from the patient's own body, making it a natural and safe option with minimal side effects. This treatment, known as platelet-rich plasma (PRP), has shown effectiveness in improving the firmness, elasticity, hydration, and thickness of the vulva and vagina. However, further research is required to assess the effectiveness of PRP specifically in the external female genital area. What is PRP - Platelet-Rich Plasma? PRP is a substance obtained from the patient's own blood. Blood is composed of several components, including red blood cells, white blood cells, plasma, and platelets. Platelets are small cell fragments that play a crucial role in blood clotting and wound healing. PRP is created by taking a small sample of the patient's blood and processing it in a centrifuge to concentrate the platelets within the plasma. This concentrated plasma, rich in growth factors and proteins, is then injected into the target area to stimulate tissue regeneration and repair. Because PRP is derived from the patient's own body, it is considered a natural and safe treatment with a very low risk of adverse reactions. PRP is obtained by collecting a small amount of the patient's blood. After a carefully standardized preparation process, the PRP is injected into the vulvovaginal area under local anesthesia. Study Location: Gynecology Department of Santo André Hospital, Leiria, at the Genital Atrophy Clinic. Study Protocol: * Initial evaluation consultation. * First treatment intervention. * Follow up approximately one month after the first treatment and second treatment intervention. * Another follow-up approximately one month after the second treatment. * Final evaluation six months after the start of the study. Participants are divided into two groups: one group receives PRP treatment, while the other receives a placebo (serum). At the end of the study, participants in the placebo group will have the option to undergo PRP treatment. This is a double-blind study designed to evaluate the efficacy of PRP in the female external genital area.
NCT06828640
This is a randomized, controlled trial aiming to evaluate the effectiveness of adding vaginal dilators to the treatment of vulvovaginal atrophy. Study Population: Peri- and postmenopausal women with VVA, including breast cancer survivors. Design: Monocentric pilot RCT evaluating SoC (MHT, lubricants, moisturizers) (control group) to SoC + vaginal dilators (test group). Vaginal Dilator : A silicone medical device will be used for gradual stretching progression. The kit includes dilators of progressively larger sizes. Procedures: Assessments at baseline, at 4 \& 12 weeks Measures : Vulvo Vaginal Atrophy severity , dyspareunia, Vaginal Health Index Score, Female Sexual Fonction Index, and Visual Analogue Scale (for vaginal dryness, vaginal and/or vulvar irritation/itching, and pain during sexual intercourse). Statistical Analysis: Differences at baseline, 4 weeks, and 12 weeks will be tested using: Two-sample t-test Mann-Whitney test Statistical Power: Assuming a 20% improvement in Group 1 and 40% in Group 2, with: p \< 0.05 (type I error) 80% power (type II error), 160 patients needed across both groups. SoC = Standard of care RCT = Randimized control trial MHT = Menopausal hormonal therapy