Efficacy and Safety of Non-hormonal Vaginal Preparations in Treating Vaginal Dryness

Launched by DR. AUGUST WOLFF GMBH & CO. KG ARZNEIMITTEL · Oct 17, 2014

Keywords

ClinConnect Summary

The purpose of the study was to test the non-inferiority of the medical device Vagisan® Moisturising Cream (VMC) in comparison to Gynomunal® vaginal gel (GVG) in 6 centres in 120 women who suffered from "vaginal dryness". The main objective criterion was to compare the sum of 4 subjective symptoms of "vaginal dryness" measured daily over a period of 28 days. VMC should be applied daily, while GVG had to be administered daily during the first week and twice weekly thereafter.

The main objective parameter for efficacy analysis was the sum of the subjective symptoms of vaginal dryness (feelin...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women over the age of 18.
• • Women with vaginal dryness who do not want to or are not allowed to use oestrogens, such as post-menopausal women, women with oestrogen-dependent tumours in their medical history and women who had been treated with systemic medicinal products that can have a drying-out effect on the vaginal mucous membranes.
• • Total score (0-16) of at least 3 of four subjective symptoms (feeling of dryness, itching, burning sensation and pain).
• • Written declaration of consent for the voluntary participation in the study is present.
• Exclusion Criteria:
• • Known hypersensitivity to one of the ingredients of the test and/or reference medical device.
• • Current vaginal infections.
• • Recurring (i.e. at least 3) vaginal infections within the last 12 months.
• • Additional (not study-related) treatment of vaginal dryness during the therapy phases.
• • Therapy with antibiotics, steroids (excluding sexual steroids in oral, dermal or transdermal application) or antimycotics in the last 14 days before inclusion and participation in this study.
• • Women who are not able to participate properly in this study.
• • Fertile women without sufficient contraceptive protection.
• • Fertile women who are pregnant (positive HCG test) or breastfeeding.
• • Current alcohol and/or drug abuse.
• • Participation in another clinical study within the last four weeks and/or parallel participation in this study.