Humectant Activity of a New Formulation of Gynomunal® Vaginalgel (GYNOMUNAL®)

Humectant Activity of a New Formulation of Gynomunal® Vaginalgel: Crossover Test Use Versus Previous Formula

Aim of the study is to evaluate the humectant activity and the local tolerability of a new formulation of Gynomunal® vaginalgel in menopausal women (menopause since at least 2 years) with referred vaginal dryness

Study Overview

• Status: Completed
• Conditions: Menopause; Vaginal Dryness
• Intervention / Treatment: Drug: Hyaluronic Acid

Detailed Description

Randomized, controlled, crossover clinical study; the subjects will use both formulations with an interval of 1 week (wash out period), in reversed sequence according to the treatment arm assigned at each subject during the basal visit.

Both tested products will be applied in the vagina, using the dedicated applicator, once a day, preferably at bedtime. To investigate the activity of the products under study, 4 visits will be performed: a baseline visit (T0), a visit at the end of the first week-treatment (T1), a visit at the end of the wash out period (T2) and a final visit at the end of the second week-treatment (T3).

Volunteers will be asked to follow their normal life and sexual habits, except for not having sexual intercourse 48 hours prior to each examination.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • MB
    • Monza, MB, Italy, 20900
      • DermIng S.r.l

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Caucasian healthy female subjects,
• complaining vaginal dryness,
• women in menopause since at least 2 years; the starting period of menopause being defined as the date when the last menstruation or metrorragia linked to hormonal unbalance took place,
• women who agree not to start a replacement therapy during the whole duration of the study,
• women who do not present any active cutaneous pathology of external and internal genitalia,
• women who did not receive any drug or cosmetic treatment on their genitalia during the 2 months preceding the trial,
• women who did not apply vaginal products within at least 1 month before the inclusion in the study,
• women who accept to use only the products authorised by the protocol,
• women who accept not to undertake any treatment for internal and external genitalia during the trial,
• women who did not use, phytoestrogenes based products on treated areas less than 4 weeks before inclusion time,
• women accepting to sign the Informed consent form,
• women able to read the material dedicated to volunteers, to abide by the rules of the protocol and ready to accept its constraints

Exclusion Criteria:

• Volunteers not fulfilling inclusion criteria,
• severe symptoms of vaginal dryness, associated with mucosal signs
• history of intolerance to a vaginal product,
• concomitant participation to another trial,
• refusal to sign the Informed Consent form,
• known allergy to one or several ingredients of the product on trial,
• change in the normal habits in the last 3 months,
• participation in a similar study during the previous 3 months,
• whose insufficient adhesion to the study protocol is foreseeable
• women who start a replacement therapy during the trial
• women who experience during the study the occurrence of any foreseeable risk to use daily the product on trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I: vaginal gel new formulation; Application once a day at evening during the first study week of the vaginal gel new formulation (hyaluronic acid). One week of wash-out (second week). Application once a day at evening during the third study week of the vaginal gel on the market (hyaluronic acid).	Drug: Hyaluronic Acid; Arm I: new formulation applied for the first week, formulation on the marked applied for the third week (second week - wash out period) Arm II: formulation on the marked applied for the first week, new formulation applied for the third week (second week - wash out period); Other Names: Gynomunal® Vaginalgel (GYNOMUNAL®)
Active Comparator: Arm II: vaginal gel on the market; Application once a day at evening during the first study week of the vaginal gel on the market (hyaluronic acid). One week of wash-out (second week). Application once a day at evening during the third study week of the vaginal new formulation (hyluronic acid).	Drug: Hyaluronic Acid; Arm I: new formulation applied for the first week, formulation on the marked applied for the third week (second week - wash out period) Arm II: formulation on the marked applied for the first week, new formulation applied for the third week (second week - wash out period); Other Names: Gynomunal® Vaginalgel (GYNOMUNAL®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vaginal Humidity determination	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Tolerability assessment	2 weeks

Collaborators and Investigators

• Sponsor: Derming SRL
• Investigators: Principal Investigator: Adele Sparavigna, Physician, DermIng SRL

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: September 6, 2013
• First Submitted That Met QC Criteria: September 19, 2013
• First Posted (Estimate): September 23, 2013

Study Record Updates

• Last Update Posted (Estimate): September 23, 2013
• Last Update Submitted That Met QC Criteria: September 19, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: menopause; vaginal dryness; hyaluronic acid
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: E0513