دورية أكاديمية
أعرض في EDS

Real‑world performance and safety of vaginal ovules in reducing the vaginal symptoms associated with vulvovaginal atrophy and postmenopausal sexual dysfunction.

التفاصيل البيبلوغرافية
العنوان: Real‑world performance and safety of vaginal ovules in reducing the vaginal symptoms associated with vulvovaginal atrophy and postmenopausal sexual dysfunction.
المؤلفون: Iliescu DG; Department of Obstetrics and Gynecology, University of Medicine and Pharmacy Craiova, 200349 Craiova, Romania., Petrita R; Biometrics Unit, MDX Research, 300633 Timisoara, Romania., Teodorescu C; Department of Obstetrics and Gynecology, 'Nicolae Malaxa' Clinical Hospital, 022441 Bucharest, Romania., Olaru RA; Department of Obstetrics and Gynecology III, National Institute Alessandrescu Rusescu, Clinic of Obstetrics and Gynecology 'Polizu', 011061 Bucharest, Romania., Alexa AA; Department of Biochemistry IV, University of Medicine and Pharmacy Victor Babes, 300041 Timisoara, Romania., Petre I; Department of Obstetrics and Gynecology XII, University of Medicine and Pharmacy Victor Babes, 300041 Timisoara, Romania.
المصدر: Biomedical reports [Biomed Rep] 2024 Jan 09; Vol. 20 (3), pp. 35. Date of Electronic Publication: 2024 Jan 09 (Print Publication: 2024).
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: [Spandidos Publications] Country of Publication: England NLM ID: 101613227 Publication Model: eCollection Cited Medium: Internet ISSN: 2049-9442 (Electronic) Linking ISSN: 20499434 NLM ISO Abbreviation: Biomed Rep Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: [London] : [Spandidos Publications], [2013]-
مستخلص: Decreasing estrogen levels during the postmenopausal period results in tissue atrophy and physiological changes, such as thinning of the vaginal epithelium, prolapse and decreased pelvic floor strength and control. Sexual dysfunction associated with vaginal dryness occurs in postmenopausal patients. The present study (trial no. NCT05654610) was designed as an observational, multicenter, real-world clinical investigation to evaluate the performance and safety of the medical device Halova ® ovules in decreasing vaginal symptoms associated with vulvovaginal atrophy and sexual dysfunction. A total of 249 female participants were treated with Halova ovules, both in monotherapy and in combination with vaginal lubricants. The primary objective was to evaluate the tolerability of Halova ovules in the management of symptoms associated with perimenopause or genitourinary syndrome of menopause. The evolution of clinical manifestations such as vaginal dryness, dysuria, dyspareunia and endometrial thickness was defined a secondary objective. Halova ovules were rated with 'excellent' clinical performance by 92.74% of participants as a standalone treatment and 95.71% of the study participants when used in association with vaginal lubricants. Sexual dysfunction-associated parameters, such as vaginal dryness and dyspareunia, were reduced by similar percentages in each arm, 82% (monotherapy) and 80% (polytherapy) for vaginal dryness and 72% in monotherapy vs. 48% polytherapy reducing dyspareunia. No adverse reactions associated with treatment with Halova were reported. The medical device demonstrated anti-atrophic activity in the genitourinary tract, resulting in significantly improved symptoms associated with normal sexual functioning.
Competing Interests: The authors declare that they have no competing interests.
(Copyright: © Iliescu et al.)
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فهرسة مساهمة: Keywords: medical device; menopause; natural lubrication; perimenopause; sexual dysfunction; vaginal dryness; vaginal pH; vulvovaginal atrophy
تواريخ الأحداث: Date Created: 20240205 Latest Revision: 20240206
رمز التحديث: 20240206
مُعرف محوري في PubMed: PMC10831781
DOI: 10.3892/br.2024.1723
PMID: 38312435
قاعدة البيانات: MEDLINE
الوصف
تدمد:2049-9442
DOI:10.3892/br.2024.1723