Efficacy, tolerability and safety of a new medical device, Monurelle Biogel(®) vaginal gel, in the treatment of vaginal dryness: a randomized clinical trial in women of reproductive age.
Eur J Obstet Gynecol Reprod Biol
; 203: 82-8, 2016 Aug.
Article
en En
| MEDLINE
| ID: mdl-27261817
ABSTRACT
OBJECTIVE:
To prove the efficacy, tolerability and safety of Monurelle Biogel(®) (ZP-025) vaginal gel, which contains a purified, dialyzed, lyophilized bovine colostrum, in women of reproductive age suffering from vaginal dryness.DESIGN:
Randomized clinical trial (RCT) (Z7213M01).SETTING:
Five University Gynaecological Units. PATIENTS Ninety-five subjects were allocated at random to receive either ZP-025 (n=48) for about 23 intermenstrual days (1 or 2 times/daily intra-vaginally) or no treatment (lubricants on demand were allowed). MAIN OUTCOMEMEASURES:
Change of Verbal Rating Scale (VRS) total and single score for vaginal symptoms, Vaginal Health Index (VHI) score, Female Sexual Function index (FSFI) and Female Sexual Distress Scale-revised (FSDS-R) scores.RESULTS:
A total number of 85 subjects was evaluable for primary analyses. Symptoms (VRS) of vaginal discomfort improved significantly already after 11 days, as compared to the control arm (p<0.0001). The mean VHI score was also significantly higher in ZP-025 group (p<0.001) at the end of the study. The analysis of covariance with the baseline value as covariate carried out on the FSFI Total Score showed a statistically significant difference in favour of the ZP-025 arm (p<0.032). A shift from presence to absence of sexual distress (≤11 points) was more prominent in the ZP-025 arm [10 subjects (40%) in the ZP-025 arm (p<0.0001) and 6 subjects (21.4%) in the control arm (p=0.01)]. Women reported a compliance rate of 100% for one ZP-025 application/day. Local tolerability of ZP-025 was excellent or good in 82.9% of the subjects.CONCLUSIONS:
The present multicentre RCT supports the use of Monurelle Biogel(®) in women of reproductive age reporting symptoms of vaginal dryness. A positive impact on vaginal health and sexual function was also evident.Palabras clave
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Bases de datos:
MEDLINE
Asunto principal:
Cremas, Espumas y Geles Vaginales
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Enfermedades Vaginales
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Libido
Tipo de estudio:
Clinical_trials
Idioma:
En
Revista:
Eur J Obstet Gynecol Reprod Biol
Año:
2016
Tipo del documento:
Article