Clinically Proven Effectiveness of Our Hyaluronic Acid-Based Vaginal Medical Device for Women’s Intimate Health
Gruppo FarmaImpresa is proud to share the results of its clinical study, conducted on the medical device Revaginal Ovules. The study evaluated the safety and effectiveness of our vaginal ovules in promoting vaginal and uterine tissue regeneration, offering an innovative and hormone-free solution for the treatment of vulvar dystrophy and related symptoms.
The product proved to be highly effective and well tolerated in women of childbearing age, perimenopause, and menopause, and is also compatible with condom use. These findings highlight the safety, tolerability, and therapeutic value of Revaginal ovules in supporting women’s vaginal health.
Understanding Vaginal Health and Regeneration
The vagina is a complex and sensitive organ, highly influenced by hormonal fluctuations over a woman’s lifetime and menstrual cycle. Its microbiota plays a crucial role in protecting against external agents. However, factors such as hormonal changes, antibiotic or contraceptive use, sexual activity, and stress can disrupt this delicate balance.
Vaginitis, an inflammation of the vaginal mucosa that may also affect the vulva, is among the most common reasons women seek medical care. It presents symptoms like burning, itching, irritation, unusual discharge, and general discomfort. Bacterial vaginosis (BV) is the most widespread form, affecting millions of women worldwide.
Revaginal Ovules was formulated to restore balance and promote vaginal tissue regeneration. Its formula includes:
- Hyaluronic Acid
- Lactic Acid
- Policarbophil
- Glycyrrhetinic Acid
- Vitamins A and E
- Tea Tree Oil
These ingredients work synergistically to promote healing of the cervical and vaginal tissues, maintain a healthy vaginal environment, and support microbiota balance.
Clinical Study: Methodology & Results
The clinical study involved 20 women, aged between 29 and 74 years. All participants presented with vulvovaginal symptoms such as burning, dryness, irritation, dysuria, and dyspareunia. To evaluate the effectiveness of FT.CE.110, the Vulvovaginal Symptom Questionnaire (VSQ) was administered before (T0) and after (T1) treatment with the vaginal suppositories.
The VSQ is a validated tool specifically designed to measure vulvovaginal symptoms and their impact on daily life, emotions, and sexuality. Statistical analysis, conducted using a paired t-test, revealed a significant difference in the overall questionnaire score before and after treatment (p-value = 0.0000). This confirms the VSQ as an effective instrument for assessing symptom improvement and enhancing the vaginal quality of life in the study participants.
The clinical results demonstrated a remarkable improvement in vulvovaginal tissue regeneration.
The overall score decreased by an average of 8.8 points, corresponding to an 89% improvement from T0 to T1. In 75% of the patients, the VSQ score at T1 was 0, indicating a complete resolution of all vulvovaginal symptoms as well as the emotional and quality-of-life impacts associated with them.
Negative emotions, such as frustration and worry, were reported by 70% of participants at the beginning of the study and dropped to 13% after treatment.
Regarding the impact on life, the most affected factor—loss of desire for intimacy—was initially present in 70% of participants and decreased to 25% post-treatment.
Sexual impact was reported by 80% of women before using the device, dropping sharply to 13% after treatment. Similarly, dyspareunia (pain during intercourse) was reduced from 60% to 19%. These results highlight the effectiveness of Revaginal Ovules as a solution for dyspareunia, significantly improving women’s intimate quality of life.
Before treatment, the most common vulvovaginal symptoms were vulvar dryness (60%), vaginal irritation (65%), and burning (60%). After using Revaginal Ovules, these symptoms were significantly reduced to 6%, 6%, and 0%, respectively.
These outcomes confirm the clinical effectiveness of Revaginal Ovules in treating vulvar dystrophy, positioning it among the most effective natural remedies for vaginal burning, and as a leading solution for vaginal dryness in menopause and irritation in reproductive-age women.
This study demonstrates that Revaginal Ovules have a significant impact on both symptoms and the overall quality of life, making it a valid vaginal treatment for women of all ages facing intimate discomfort. No adverse events were reported during the study.
Gruppo FarmaImpresa remains committed to advancing research and developing solutions that promote female intimate health, supporting vaginal regeneration and improving women’s well-being at every stage of life.
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