Humectant Activity of a New Formulation of Gynomunal® Vaginalgel | RxWiki

Humectant Activity of a New Formulation of Gynomunal® Vaginalgel

Overview[ - collapse ][ - ]

Purpose	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
Condition	Vaginal Dryness Menopause
Intervention	Drug: Hyaluronic Acid
Phase	Phase 4
Sponsor	Derming SRL
Responsible Party	Derming SRL
ClinicalTrials.gov Identifier	NCT01948583
First Received	September 6, 2013
Last Updated	September 19, 2013
Last verified	September 2013

Tracking Information[ + expand ][ + ]

First Received Date	September 6, 2013
Last Updated Date	September 19, 2013
Start Date	May 2013
Estimated Primary Completion Date	July 2013
Current Primary Outcome Measures	Vaginal Humidity determination [Time Frame: 2 weeks] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	Tolerability assessment [Time Frame: 2 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Humectant Activity of a New Formulation of Gynomunal® Vaginalgel
Official Title	Humectant Activity of a New Formulation of Gynomunal® Vaginalgel: Crossover Test Use Versus Previous Formula
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
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
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Vaginal Dryness Menopause
Intervention	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®)
Study Arm (s)	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). 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).

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	28
Estimated Completion Date	July 2013
Estimated Primary Completion Date	May 2013
Eligibility 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.
Gender	Female
Ages	N/A
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Italy

Administrative Information[ + expand ][ + ]

NCT Number	NCT01948583
Other Study ID Numbers	E0513
Has Data Monitoring Committee	Yes
Information Provided By	Derming SRL
Study Sponsor	Derming SRL
Collaborators	Not Provided
Investigators	Principal Investigator: Adele Sparavigna, Physician Derming SRL
Verification Date	September 2013

Locations[ + expand ][ + ]