Tibolone vaginal versus per os administration in the management of post-menopausal symptoms

Tibolone is a selective tissue estrogenic activity regulator effective in the management of climacteric symptoms, without stimulating endometrial and breast tissue proliferation. It is a well-tolerated treatment regimen with minor adverse effects. The purpose of the current trial was to investigate the efficacy of tibolone administration per os versus per vaginal, concerning the treatment of climacteric symptoms.

A total of 64 post-menopausal healthy women aged 44-55 years (mean 52,5) were enrolled in the study. The patients were divided into three groups: Group A with 24 patients receiving per os Tibolone 2.5 mg x 1 daily for 6 months, Group B with 21 patients receiving vaginally Tibolone 2.5 mg x 1 for 6 months and Group C--with 19 patients receiving only hygienodietetics advices and psychological support for 6 months. All subjects underwent a physical examination, including a transvaginal ultrasonography for the measurement of endometrial thickness and a mammography for the assessment of breast density.

In Group A and B, climacteric symptoms were similarly reduced with non significant differences between groups: 79% (19 patients) vs 76% (16 patients) reduction for hot flushes and 83% (20 patients) vs 76% (16 patients) for sweating episodes respectively (p > 0.05). Reduction of hot flushes and sweating episodes was observed in only 2 of 19 patients (10.5%) in group C (p < 0.01). Vaginal route had better results on vaginal dryness-dyspareunia in group B (in 14 patients taken tibolone orally-58% vs 16 patients taken tibolone vaginally-76%). No statistically significant difference was found related to urine symptoms between A and B groups. Tibolone by vaginal route did not cause any severe side effects (apart of a slight discharge) and it was equally (or better) tolerated than oral route. No significant alterations in breast density and BIRADS and no increase in endometrial thickness were observed in all study groups.

Tibolone is effective in relieving climacteric symptoms indifferent from applications-modus: orally or vaginally. However, further and larger studies are required to confirm results.