Safety and Efficacy of an Oxytocin Gel and an Equivalent Gel but Without Hormonal Ingredients (Vagivital® Gel) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy: A Randomized, Double-Blind Controlled Study
| Autor: | Mikael Åstrom, Inger Sundström Poromaa, Marie Bixo, Aino Fianu Jonasson |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
business.industry Biomedical Engineering Medicine (miscellaneous) 030209 endocrinology & metabolism medicine.disease Gastroenterology law.invention 03 medical and health sciences 0302 clinical medicine Breast cancer Tolerability Randomized controlled trial Oxytocin law Internal medicine medicine Itching Dysuria medicine.symptom business Adverse effect 030217 neurology & neurosurgery medicine.drug Hormone |
| Zdroj: | Medical Devices: Evidence and Research. 13:339-347 |
| ISSN: | 1179-1470 |
| DOI: | 10.2147/mder.s265824 |
| Popis: | Purpose The primary objective was to compare the efficacy of 12 weeks of daily treatment with Aqueous Hypromellose-based vaginal (Vagivital®) gel versus Aqueous Hypromellose-based vaginal gel plus 400 IU oxytocin gel in reducing the severity of the most bothersome vulvovaginal atrophy symptoms (MBS: itching, dysuria, bleeding, and pain/discomfort during vaginal sexual activity) observed at baseline. The secondary objectives were to evaluate the other vulvovaginal atrophy symptoms, vaginal pH, superficial squamous cells, and the safety and tolerability of both gels. Patients and methods This double-blind, randomized study evaluated the safety and efficacy of subjects randomly assigned to 12 weeks of daily intravaginal oxytocin gel (n=79) or Aqueous Hypromellose-based vaginal gel (n=78). The efficacy evaluation was performed using data from all included subjects who fulfilled entry criteria. Results Both treatments induced statistically significant reductions in the severity of the MBS from baseline until 4 weeks (Vagivital mean reduction 0.90, p=0.0000; Oxytocin mean reduction 0.82, p=0.0000) and 12 weeks post baseline (Vagivital mean reduction 1.28, p=0.0000; Oxytocin mean reduction 1.16, p=0.0000), but the reduction of MBS severity was not significantly different between the treatment groups at either time point. No serious adverse events were reported in the Aqueous Hypromellose-based vaginal gel group during the treatment period, but one (breast cancer) was reported in the oxytocin gel group (assessed as unlikely related to the study compound). Conclusion Significant reductions in the severity of the MBS were seen in both the Aqueous Hypromellose-based vaginal gel and the oxytocin gel groups, but with no significant differences in severity reduction seen between the groups. Both gels were safe and well tolerated. Given the benefits of avoiding the use of hormones, Aqueous Hypromellose-based vaginal gel is an attractive first choice in the treatment of postmenopausal women with vulvovaginal atrophy symptoms. |
| Databáze: | OpenAIRE |
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