Clinical trial NCT02269826: Efficacy and Safety of Non-hormonal Vaginal Preparations in Treating Vaginal Dryness
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Dryness
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
First posted: 2014-10-21
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

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 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.

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.

Primary outcomes:
measure: per patient intraindividually determined total score consisting of the patients' subjective symptoms (feeling of dryness, itching, burning sensation and pain)
timeFrame: Therapy period of 28 days
Secondary outcomes:
measure: Intraindividually determined total score consisting of the evaluations of the objective "vaginal dryness" diagnoses
timeFrame: 28 days
measure: Patients' individual subjective symptoms of "vaginal dryness"
timeFrame: 28 days
measure: Overall efficacy and tolerability assessments
timeFrame: 28 days
measure: Occurrence of side effects
timeFrame: 28 days
measure: Assessment of adverse events
timeFrame: 28 days
measure: Vaginal pH
timeFrame: 28 days
measure: Patients' subjective satisfaction with the test and reference medical device
timeFrame: 28 days
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Dr. med. Kirsten Grunwald
city: Aachen
country: Germany
facility: Dr. med. Julia Wanke
city: Aachen
country: Germany
facility: Dr. med. Axel Gerick
city: Aachen
country: Germany
facility: Dr. med. Ralf Conrads
city: Stolberg
country: Germany
facility: Wolfgang Clemens
city: Würselen
country: Germany
facility: Anja Obermeyer
Study officials:
affiliation: Dr. August Wolff GmbH & Co. KG Arzneimittel
name: Christoph Abels, Prof., MD
role: STUDY_DIRECTOR
name: Klaus-Michael Grunwald, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stute P, May TW, Masur C, Schmidts-Winkler IM. Efficacy and safety of non-hormonal remedies for vaginal dryness: open, prospective, randomized trial. Climacteric. 2015;18(4):582-9. doi: 10.3109/13697137.2015.1036854. Epub 2015 May 22.