Objective: To establish the proportion of symptomatic postmenopausal women who can be satisfactorily maintained on a low HRT dose of 25 microg/day 17-beta-estradiol (Oesclim 25 transdermal patches), after 8 weeks of treatment.
Study design and patients: This was a multicenter open label non-comparative trial. Treatment was initiated with 25 microg/day dosage, which could be increased to 50pg/day if required after 8 weeks, according to clinical evaluation. Sequential treatment with an oral progestogen was also given for > or = 12 days/month in all non-hysterectomized women. The primary criterion for evaluation of efficacy was the proportion of patients who remained on Oesclim 25 after 8 weeks of treatment in comparison to patients requiring Oesclim 50.
Results: Sixty-two patients were included in the study and 60 were treated. 88.3% of treated patients [CI: 78.7-94.9] fulfilled the primary criterion, remaining with the Oesclim 25 dosage after 8 weeks of treatment. All clinical menopausal symptoms showed a decrease from baseline to the end of the study. The mean daily number of vasomotor symptoms decreased from 8.2 (+/- 5.6) at baseline, for the entire treated population, to 1.0 (+/- 2.2) and 1.0 (+/- 1.2) at the end of the study in patients remaining with Oesclim 25 and in those requiring Oesclim 50, respectively. At the interim visit, patients in the Oesclim 50 group had a higher number of symptoms than those maintained on Oesclim 25. The global efficacy of the treatment was evaluated as very effective/effective by 93% of all patients and very good/good by investigators for 91% of their patients. Overall 91% of all patients evaluated the global tolerability as very well/well, while investigators rated it very good/good for 97% of their patients. The vast majority of all patients (93%) were very satisfied/satisfied with the trial treatment, and 90% of them were willing to continue the study drug.
Conclusion: Oesclim low dose (25microg) hormonal transdermal therapy was efficient in management of climacteric symptoms in this 16-week study. The good acceptance of the treatment was associated with its high efficiency and tolerability.