Clinical Data

Study design

The present study was designed as part of a medical device post-marketing clinical follow-up, involving routine care from a number of clinical practices. The study had an open-label, multicenter, non-randomized, real-world evidence study design. The total duration of the study was 30 days. The medical device was applied once daily, during days 1-10. The data were collected between March and July 2022.

Study population

The participant population included female patients aged 18-70 years of Caucasian ethnicity with clinical manifestations associated with the following conditions: Dryness in the vaginal region, perimenopause, vulvovaginal atrophy, menopausal disorder or vaginal prolapse. A total of 249 patients were evaluated; 179 patients received Halova ovules as monotherapy, while 70 used Halova ovules in association with vaginal lubricants (polytherapy).

Results

According to the study, Halova® ovules in monotherapy achieved the following results at the 30-day evaluation:

• Excellent clinical performance: 92.74% of participants
• Absence of vaginal dryness: 82%
• Absence of dyspareunia: 72%
• Patient satisfaction ‘excellent’: 94.38%
• 0% adverse reactions reported.
• Halova® significantly alleviates symptoms such as vaginal dryness, dyspareunia, and dysuria, while restoring normal pH and thereby harnessing the protective properties of the vaginal microbiome.
  • Halova® has proven safe and effective in alleviating the main bothersome signs and symptoms of atrophic vaginitis in postmenopausal women, such as dysuria, dyspareunia, and vaginal dryness.
  • Halova® may represent an excellent therapeutic alternative for patients in whom local estrogenic treatment remains controversial.
• Applied once daily for 10 consecutive days, Halova® may represent a suitable treatment option for vulvovaginal atrophy and urogenital complaints in both women of reproductive age and postmenopausal women.