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[Hormone substitution with premarin plus. Results of an Austrian multicenter treatment study]
T Kazar1, K Neumann, E Windsteig
1Wyeth Osterreich, Wien.
Abstract:
Estrogen/progestin hormone replacement therapy in menopausal women has 2 important medical rationales. First of all, patients are relieved from the subjective symptoms almost fully. In addition patients benefit from prophylaxis of long term even life threatening sequelae of estrogen deficiency. This paper documents the results of a multicenter phase IV study, performed nationwide in Austria with 158 participating gynaecologists. Objective of this phase IV study was the analysis of efficacy and safety data of a new estrogen/progestin hormone replacement therapy scheme under almost practice conditions in the gynaecological context. The therapy supplied was Premarin plus, containing 28 coated tablets of 0.625 or 1.25 mg conjugated estrogens and in addition 12 tablets for the last cycle days containing 5 mg medrogeston. Thus, the dispensing gynaecologists had the option of an individual estrogen dose adjustment in case the low starting dose showed lack of efficacy. The results are based on the data of 1508 recruited female patients. A very high degree of representativeness is attributable to the high number of recruited patients. Overall judgement of the results shows a very high level of efficacy and a well tolerated scheme of hormone replacement therapy with the option of individual estrogen dose adjustments.