Humectant Activity of a New Formulation of Gynomunal® Vaginalgel

NCT01948583 | Completed Phase 4 DMC

• 1 other identifier: E0513
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vaginal Dryness; Menopause

Keywords

vaginal dryness; hyaluronic acid; menopause

Outcome Measures

Primary Outcomes (1)

• Vaginal Humidity determination

  2 weeks

Secondary Outcomes (1)

• Tolerability assessment

  2 weeks

Study Arms (2)

Arm I: vaginal gel new formulation

ACTIVE COMPARATOR

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 II: vaginal gel on the market

ACTIVE COMPARATOR

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

Interventions

Hyaluronic Acid DRUG

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)

Also known as: Gynomunal® Vaginalgel (GYNOMUNAL®)

Arm I: vaginal gel new formulation; Arm II: vaginal gel on the market

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DermIng S.r.l

Monza, MB, 20900, Italy

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Adele Sparavigna, Physician

  Derming SRL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 23, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 23, 2013

Record last verified: 2013-09

Locations

IT (1)