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

Rossella E. Nappi, Chiara Benedetto, Federica Campolo, Silvia Martella, Claudia Tosti, Antonio Cianci, Salvatore Caruso, Secondo Guaschino, Eva Grimaldi, Massimo Bagolan, Marco Sardina

Research output: Contribution to journalArticle

2 Citations (Scopus)

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 outcome measures 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.

Original languageEnglish
Pages (from-to)82-88
Number of pages7
JournalEuropean Journal of Obstetrics, Gynecology and Reproductive Biology
Volume203
DOIs
Publication statusPublished - Aug 1 2016

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Foams and Jellies Vaginal Creams
Randomized Controlled Trials
Safety
Equipment and Supplies
Lubricants
Colostrum
Age Factors
Reproductive Health
Health
Therapeutics
Outcome Assessment (Health Care)

Keywords

  • Colostrum
  • Reproductive age
  • Sexual function
  • Vaginal dryness
  • Vaginal gel

ASJC Scopus subject areas

  • Obstetrics and Gynaecology
  • Reproductive Medicine

Cite this

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. / Nappi, Rossella E.; Benedetto, Chiara; Campolo, Federica; Martella, Silvia; Tosti, Claudia; Cianci, Antonio; Caruso, Salvatore; Guaschino, Secondo; Grimaldi, Eva; Bagolan, Massimo; Sardina, Marco.

In: European Journal of Obstetrics, Gynecology and Reproductive Biology, Vol. 203, 01.08.2016, p. 82-88.

Research output: Contribution to journalArticle

Nappi, Rossella E. ; Benedetto, Chiara ; Campolo, Federica ; Martella, Silvia ; Tosti, Claudia ; Cianci, Antonio ; Caruso, Salvatore ; Guaschino, Secondo ; Grimaldi, Eva ; Bagolan, Massimo ; Sardina, Marco. / 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. In: European Journal of Obstetrics, Gynecology and Reproductive Biology. 2016 ; Vol. 203. pp. 82-88.
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abstract = "Objective To prove the efficacy, tolerability and safety of Monurelle Biogel{\circledR} (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 outcome measures 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{\circledR} in women of reproductive age reporting symptoms of vaginal dryness. A positive impact on vaginal health and sexual function was also evident.",
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AU - Benedetto, Chiara

AU - Campolo, Federica

AU - Martella, Silvia

AU - Tosti, Claudia

AU - Cianci, Antonio

AU - Caruso, Salvatore

AU - Guaschino, Secondo

AU - Grimaldi, Eva

AU - Bagolan, Massimo

AU - Sardina, Marco

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N2 - 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 outcome measures 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.

AB - 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 outcome measures 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.

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