Status:
COMPLETED
Efficacy and Safety of Non-hormonal Vaginal Preparations in Treating Vaginal Dryness
Lead Sponsor:
Dr. August Wolff GmbH & Co. KG Arzneimittel
Conditions:
Vaginal Dryness
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Vulvovaginal irritation due to dryness is a frequent complaint among post- and some premenopausal women. International guidelines recommend non-hormonal products as first line therapy. Efficacy and s...
Detailed Description
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 fr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT02269826
Start Date
February 1 2008
End Date
December 1 2008
Last Update
February 19 2018
Active Locations (6)
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1
Dr. med. Kirsten Grunwald
Aachen, Germany, 52064
2
Dr. med. Julia Wanke
Aachen, Germany, 52070
3
Dr. med. Axel Gerick
Aachen, Germany, 52072
4
Dr. med. Ralf Conrads
Aachen, Germany, 52078