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.
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 (feeling of dryness, itching, burning sensation and pain) before, during (patient diaries) and after the 28-day therapy period. The per-protocol analysis and of the intent-to-treat analysis should prove non-inferiority of VMC compared to GVG, despite a possible carry-over effect to the detriment of VMC. To avoid the problem of any possible carry-over effect the analysis of the first period was chosen for the primary comparison of both products. Furthermore, objective symptoms of vaginal dryness detected via colposcopy, the vaginal secretion's pH, the efficacy assessment by the patients and the treating doctor and patients' questionnaires with regard to the product characteristics of the medical devices should be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
117
Once in the evenings before going to bed, intravaginally with the help of the applicator included (approximately 2.5 g per application) and perivaginally one fingertip unit (approximately 0.5 g per application).
Once in the evenings before going to bed, intravaginally with the help of the applicator included (approximately 2.5 g per application) and perivaginally one fingertip unit (approximately 0.5 g per application).
Dr. med. Kirsten Grunwald
Aachen, Germany
Dr. med. Julia Wanke
Aachen, Germany
Dr. med. Axel Gerick
Aachen, Germany
Dr. med. Ralf Conrads
Aachen, Germany
Wolfgang Clemens
Stolberg, Germany
Anja Obermeyer
Würselen, Germany
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.
Time frame: Therapy period of 28 days
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).
Time frame: 28 days
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).
Time frame: 28 days
Overall efficacy and tolerability assessments
The overall efficacy and tolerability assessments (investigator and/or patient) with the ratings "very good", "good", "satisfactory" and "poor".
Time frame: 28 days
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
Time frame: 28 days
Assessment of adverse events
The assessment of adverse events that have not been classified as related to the medical device.
Time frame: 28 days
Vaginal pH
Descriptive account of the vaginal pH as determined by the investigator during the visits.
Time frame: 28 days
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").
Time frame: 28 days
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