Clinical trial NCT02994342: Efficacy and Tolerability Study of ZP-025 Vaginal Gel for the Treatment of Vaginal Dryness
Official title: Efficacy, Tolerability and Safety of a New Medical Device, Zp-025 Vaginal Gel, in the Treatment of Vaginal Dryness in Post-menopausal Women With Vaginal Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Dryness
Keywords: vaginal dryness
vaginal gel
colostrum
vaginal atrophy
Lead sponsor: Zambon SpA
Sponsor class: INDUSTRY
First posted: 2016-12-15
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of ZP-025 vaginal gel in terms of efficacy and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy after 56 consecutive days and at 4-week follow-up only for women applying ZP-025 vaginal gel.

Detailed description: Evaluation of ZP-025 vaginal gel in terms of efficacy, tolerability and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy for 56 consecutive days.

This trial will be conducted in compliance with last version of Declaration of Helsinki, with GCP as applicable to investigations with IMD, with the applicable regulatory requirements and with CRO and Sponsor's SOPs.

This is a multi-centre, national, randomized, controlled vs. no-treatment, open label study The study will take place in 6 centers of menopause at public Hospitals/Universities. An ancillary study will be carried on for subjects randomized to ZP-025 group with a follow-up visit at 4 weeks

Eligibility criteria: Inclusion Criteria:

* caucasian women \<70 years, in physiological postmenopausal status for at least 2 years;
* women with signs and symptoms of vaginal atrophy (i. e. vaginal discomfort, itching, dyspareunia, dryness);
* signed informed consent; willing and able to comply with study procedures

Exclusion Criteria:

* childbearing potential women;
* ascertained or presumptive hypersensitivity to the formulation ingredients;
* therapy with systemic or vaginal oestrogens within 6 months from the inclusion;
* current urinary or vaginal infection (cultural positive result to vaginal or urines microbiological swab in the 7 days preceding inclusion);
* previous episodes of vaginal bleeding or spotting in the last 6 months;
* vaginal prolapse and any other disease that could interfere with the study conduction and participation

Primary outcomes:
measure: Change in subjective symptoms of total score related to vaginal discomfort
timeFrame: 56 days
Secondary outcomes:
measure: change of vaginal health index
timeFrame: 56 days
measure: change of maturation index
timeFrame: 56 days
measure: change of Female Sexual Function Index
timeFrame: 56 days
measure: change in each subjective symptom score related to vaginal discomfort
timeFrame: 56 days
measure: local tolerability and incidence of adverse events
timeFrame: 56 days
measure: change of Female Sexual Distress Scale-Revised
timeFrame: 56 days
measure: change of cariopicnotic index (CPI),
timeFrame: 56 days
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Ospedale San Giovanni di Dio
city: Firenze
country: Italy
facility: Policlinico Careggi
city: Milano
country: Italy
facility: Clinica Macedonio Melloni
city: Modena
country: Italy
facility: Policlinico di Modena
city: Napoli
country: Italy
facility: Policlinico Federico II
city: Pavia
country: Italy
facility: Policlinico San Matteo
Study officials:
affiliation: Obstetrics and Gynaecology Clinic IRCCS Fondazione San Matteo University of Pavia, Italy
name: Rossella Nappi, Md PhD
role: STUDY_DIRECTOR
References:
citation: Nappi RE, Cagnacci A, Becorpi AM, Nappi C, Paoletti AM, Busacca M, Martella S, Bellafronte M, Tredici Z, Di Carlo C, Corda V, Vignali M, Bagolan M, Sardina M. Monurelle Biogel(R) vaginal gel in the treatment of vaginal dryness in postmenopausal women. Climacteric. 2017 Oct;20(5):467-475. doi: 10.1080/13697137.2017.1335703. Epub 2017 Jun 28.