Efficacy and safety of non-hormonal remedies for vaginal dryness: open, prospective, randomized trial

Abstract

Objectives To prove non-inferiority of the first non-hormonal vaginal cream in Germany, Vagisan^® Moisturising Cream (CREAM), compared to a non-hormonal vaginal gel (GEL) for vulvovaginal atrophy (VVA) symptom relief.

Method This was a 12-week multicenter, open-label, prospective, randomized, two-period, cross-over phase-III trial. The primary endpoint was the cumulative VVA subjective symptom score of the respective treatment period. Secondary endpoints were assessment of single VVA subjective and objective symptoms, VVA objective symptom score, vaginal pH, safety parameters, overall assessment of efficacy, tolerability and evaluation of product properties. In total, 117 women were randomly allocated to either one of the two treatments, each administered for 4 weeks; 92 women were included in the per-protocol analysis (primary analysis). The main outcome measure was cumulative VVA subjective symptom score.

Results Regarding VVA symptom relief, results confirmed non-inferiority of CREAM compared to GEL and even indicated superiority of CREAM. Frequency and intensity of subjective symptoms and objective findings were clearly reduced, with CREAM showing better results compared to GEL. Mean VVA objective symptom score significantly decreased; improvement was significantly greater with CREAM. Vaginal pH decreased only following CREAM treatment. Tolerability was superior for CREAM: burning and itching, mostly rated as mild, occurred markedly less often with CREAM than with GEL. Overall satisfaction with treatment efficacy, tolerability and most product properties were rated significantly superior for CREAM.

Conclusions Subjective and objective VVA symptoms were reliably and safely reduced by both non-hormonal topical products. However, efficacy and tolerability of CREAM were shown to be superior to GEL.

Key words::

• VULVOVAGINAL ATROPHY
• VAGINAL DRYNESS
• VAGINAL pH
• NON-HORMONAL VAGINAL THERAPY
• VAGINAL CREAM
• VAGINAL GEL

ACKNOWLEDGEMENTS

The authors are grateful for the support of the coordinating investigator, the participating centers and the statistical support of Dieter Werdier, PhD (SAM GmbH).

Conflict of interest Petra Stute and Theodor W. May received compensation for consulting Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany.

Source of funding The study was sponsored by Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany.

Supplementary materials available online

Supplementary 1 Study centers, Supplementary Figures 2, 3 and Supplementary Table 4.