Humectant Activity of a New Formulation of Gynomunal® Vaginalgel

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Derming SRL
• Treatments: Hyaluronic Acid

Criteria

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.