NCT01948583

Humectant Activity of a New Formulation of Gynomunal® Vaginalgel

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Derming SRL · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Vaginal Dryness
• Menopause

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-05-01
• Completion: 2013-07-01
• First posted: 2013-09-23
• Last updated: 2013-09-23

Locations

1 site across 1 country: Italy