Efficacy and Tolerability of Low-dose Transdermal Estrogen (Oesclim®)in the Treatment of Menopausal Symptoms

SummaryObjective:Toestablish the proportion of symptomatic postmenopausal women who can be satisfactorily maintained on a low HRT dose of 25 μg/day 17-β-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 μg/day dosage, which could be increased to 50 μg/day if required after 8 weeks, according to clinical evaluation. Sequential treatment with an oral progestogen was also given for >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 from8.2 (±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 (25 μg) 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.