Efficacy and Tolerability Study of ZP-025 Vaginal Gel for the Treatment of Vaginal Dryness

NCT02994342 | Completed

• 1 other identifier: Z7213M02
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 6

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.

Conditions

Vaginal Dryness

Keywords

vaginal dryness; vaginal gel; colostrum; vaginal atrophy

Outcome Measures

Primary Outcomes (1)

• Change in subjective symptoms of total score related to vaginal discomfort

  Change in subjective symptoms of total score related to vaginal discomfort (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, and dyspareunia and vaginal bleeding associated with sexual activity) has been recorded on daily diary by subject from baseline to day 56, evaluated using a subjective evaluation scale (VRS at four items: 0= absent, 1= mild, 2=moderate, 3=severe). Each item is summed up to get to a total symptoms score.

  56 days

Secondary Outcomes (7)

• change of vaginal health index

  56 days

• change of maturation index

  56 days

• change of Female Sexual Function Index

  56 days

• change in each subjective symptom score related to vaginal discomfort

  56 days

• local tolerability and incidence of adverse events

  56 days

Study Arms (2)

Vaginal gel, Medical Device Class 2A

ACTIVE COMPARATOR

Every subject has been treated for 56 consecutive days, twice daily with a vaginal application

Device: Vaginal gel, Medical Device Class 2A

Lifestyle counseling

NO INTERVENTION

Every subject has been observed for 56 consecutive days

Interventions

Vaginal gel, Medical Device Class 2A DEVICE

Application twice a day of vaginal gel for 56 consecutive days

Also known as: Monurelle Biogel

Vaginal gel, Medical Device Class 2A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• childbearing potential women;
• ascertained or presumptive hypersensitivity to the formulation ingredients;
• 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

Sponsors & Collaborators

• Zambon SpA: lead

Study Sites (6)

Ospedale San Giovanni di Dio

Cagliari, Italy

Location

Policlinico Careggi

Florence, Italy

Location

Clinica Macedonio Melloni

Milan, Italy

Location

Policlinico di Modena

Modena, Italy

Location

Policlinico Federico II

Napoli, Italy

Location

Policlinico San Matteo

Pavia, Italy

Location

Related Publications (1)

• 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.

  PMID: 28657769 DERIVED

MeSH Terms

Interventions

Vaginal Creams, Foams, and Jellies

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Rossella Nappi, Md PhD

  Obstetrics and Gynaecology Clinic IRCCS Fondazione San Matteo University of Pavia, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 15, 2016
• Study Start: October 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: October 1, 2015
• Last Updated: June 28, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

IT (6)