Effectiveness and safety of vaginal suppositories for the treatment of the vaginal atrophy in postmenopausal women: an open, non-controlled clinical trial

D. Costantino, C. Guaraldi

Centro Salute Donna, Azienda USL, Ferrara (Italy)

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• Gynecology

Menopause, due to the physiological decrease in the estrogens levels, is often associated with many symptoms related to vaginal atrophy such vaginal dryness, dyspareunia, burning, itching, decreasing in libido and therefore a worsening of the quality of life and in particular of the sexual activity.
There are many pharmacological remedies to solve these events, first of all hormone replacement therapy (HRT) that up to the 90s was the therapy of choice for the care of the menopause symptoms. This hormonal therapy, however, has been re-considered due to its side effects.
As alternative, a clinical trial has been performed to investigate the efficacy and safety, in postmenopausal women with urogenital atrophy, of the use of suppositories for vaginal use, containing hyaluronic acid, vitamin E and vitamin A. The trial, according to a open, non-controlled design, was performed on 150 postmenopausal women, 1 vaginal suppository per day, for the first 14 days and then a vaginal suppository, day in and day out, for other 14 days.
The primary endpoint was the evaluation of vaginal dryness assessed by a Visual Analogue Scale (VAS) both by the investigator and the patient. The secondary endpoints were the evaluation of all the other symptoms and signs associated with the vaginal atrophy (itching, burning, dyspareunia, vaginal inflammation or swelling, irritation, assessed by a 4-point scale, presence of vaginal abrasions and irritation), and the recording of the adverse events occurring during the trial.
The patients have not reported adverse effects during the treatment, and the results in terms of effectiveness on the vaginal atrophy symptoms were markedly positive. A high level of compliance was registered.
The product tested can therefore be considered a safe and effective alternative for the treatment of vaginal atrophy symptoms in postmenopausal women, especially when HRT is not recommended.

Corresponding Author: Costantino Demetrio, MD; e-mail: kostin@alice.it