Vaginal Dryness Clinical Trial
Official title:
Medical Device Study to Investigate the Efficacy and Tolerability of Vagisan® Moisturising Cream vs. Gynomunal® Vaginal Gel in a 2-period Changeover Design in n=120 Patients With Vaginal Dryness Who Cannot or do Not Wish to Use Oestrogens
Verified date | February 2018 |
Source | Dr. August Wolff GmbH & Co. KG Arzneimittel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 safety of the medical device Vagisan® Moisturising Cream (VMC), a non-hormonal
vaginal cream for the treatment of vulvovaginal dryness and Gynomunal Vaginal Gel (GVG), a
non-hormonal gel should be compared in a 12-week multicentre, open-label, randomised,
two-period cross-over phase III trial. The hypothesis was that VMC is non-inferior to GVG.
The primary endpoint was the sum of subjective symptoms of vulvovaginal atrophy (VVA) added
up over each treatment period. Furthermore, objective symptoms of VVA and adverse effects
were planned to be assessed. 120 women should be randomly allocated to either of the two
treatments, each given over a period of 4 weeks.
Status | Completed |
Enrollment | 117 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Germany | Dr. med. Axel Gerick | Aachen | |
Germany | Dr. med. Julia Wanke | Aachen | |
Germany | Dr. med. Kirsten Grunwald | Aachen | |
Germany | Dr. med. Ralf Conrads | Aachen | |
Germany | Wolfgang Clemens | Stolberg | |
Germany | Anja Obermeyer | Würselen |
Lead Sponsor | Collaborator |
---|---|
Dr. August Wolff GmbH & Co. KG Arzneimittel |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | per patient intraindividually determined total score consisting of the patients' subjective symptoms (feeling of dryness, itching, burning sensation and pain) | The main objective criterion for the confirmatory analysis was the per patient intraindividually determined total score consisting of the patients' subjective symptoms (feeling of dryness, itching, burning sensation and pain, each rated as 0=not present, 1=hardly pronounced, 2=moderately pronounced, 3=quite pronounced, 4=very pronounced) during the course of therapy. This was based on the daily entry in the patient diary. | Therapy period of 28 days | |
Secondary | Intraindividually determined total score consisting of the evaluations of the objective "vaginal dryness" diagnoses | • Descriptive account of the per patient intraindividually determined total score consisting of the evaluations of the objective "vaginal dryness" diagnoses made by the investigator during the visits (thinning of the epithelium, redness, petechial bleeding, discharge, each rated as 0=not present, 1=hardly pronounced, 2=moderately pronounced, 3=quite pronounced, 4=very pronounced). | 28 days | |
Secondary | Patients' individual subjective symptoms of "vaginal dryness" | Descriptive account of the patients' individual subjective symptoms of "vaginal dryness" expressed during the visits (feeling of dryness, itching, burning sensation and pain). | 28 days | |
Secondary | Overall efficacy and tolerability assessments | The overall efficacy and tolerability assessments (investigator and/or patient) with the ratings "very good", "good", "satisfactory" and "poor". | 28 days | |
Secondary | Occurrence of side effects | The assessment of one-sided 95% confidence intervals for the occurrence of side effects when using the test and reference medical device | 28 days | |
Secondary | Assessment of adverse events | The assessment of adverse events that have not been classified as related to the medical device. | 28 days | |
Secondary | Vaginal pH | Descriptive account of the vaginal pH as determined by the investigator during the visits. | 28 days | |
Secondary | Patients' subjective satisfaction with the test and reference medical device | The patients' subjective satisfaction with the test and reference medical device based on a patient questionnaire conducted at the end of each treatment period [feeling of skin (within approximately 10 minutes of application and the following morning), discharge the next morning, stickiness, spreadability on the vulva (perivaginal), cooling effect, softness of the medical device, fragrance, handling of the applicator, overall assessment by the sexual partner] with ratings from 1 (very positive) to 6 (very negative) or 0=no assessment (see chapter 9.1.6 "Patient questionnaire"). | 28 days |
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