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.
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.


METHODS
Randomized clinical trial (RCT) (Z7213M01).


METHODS
Five University Gynaecological Units.


METHODS
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).


METHODS
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.
Research Centre for Reproductive Medicine, Gynaecological Endocrinology and Menopause, IRCCS S. Matteo Foundation, Italy; Dept. of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, Pavia, Italy. Electronic address: renappi@tin.it.
Rossella E
RE
Nappi
University Gynaecology and Obstetrics 1, Sant'Anna Hospital, Turin, Italy.
Chiara
C
Benedetto
University Gynaecology and Obstetrics 1, Sant'Anna Hospital, Turin, Italy.
Federica
F
Campolo
Research Centre for Reproductive Medicine, Gynaecological Endocrinology and Menopause, IRCCS S. Matteo Foundation, Italy; Dept. of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, Pavia, Italy.
Silvia
S
Martella
Obstetrics and Gynaecology Clinic, University of Siena, Italy.
Claudia
C
Tosti
Obstetrics and Gynaecology Clinic, Polyclinic of Catania, Italy.
Antonio
A
Cianci
Obstetrics and Gynaecology Clinic, Polyclinic of Catania, Italy.
Salvatore
S
Caruso
Obstetrics and Gynaecology Clinical, University of Trieste, Italy.
Secondo
S
Guaschino
Obstetrics and Gynaecology Clinical, University of Trieste, Italy.
Eva
E
Grimaldi
Zambon SpA, Bresso, Italy.
Massimo
M
Bagolan
Zambon SpA, Bresso, Italy.
Marco
M
Sardina
D000282:Administration, Intravaginal; D000328:Adult; D003126:Colostrum; D005260:Female; D006801:Humans; D007989:Libido / Q000187:drug effects*; D008875:Middle Aged; D012725:Sexual Behavior / Q000187:drug effects; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies / Q000494:pharmacology / Q000627:therapeutic use*; D014623:Vaginal Diseases / Q000188:drug therapy*; D055815:Young Adult
D014622:Vaginal Creams, Foams, and Jellies
Colostrum; Reproductive age; Sexual function; Vaginal dryness; Vaginal gel