Menopause Clinical Trial
— GYNOMUNAL®Official title:
Humectant Activity of a New Formulation of Gynomunal® Vaginalgel: Crossover Test Use Versus Previous Formula
Verified date | September 2013 |
Source | Derming SRL |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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
Status | Completed |
Enrollment | 28 |
Est. completion date | July 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | DermIng S.r.l | Monza | MB |
Lead Sponsor | Collaborator |
---|---|
Derming SRL |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vaginal Humidity determination | 2 weeks | Yes | |
Secondary | Tolerability assessment | 2 weeks | Yes |
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