Influence of the testosterone therapy (1 % transdermal gel) on the life quality of men of androgen deficiency in terms of routing clinical practice: 6 months monitoring test

Autor: A. Z. Vinarov, L. A. Spivak, I. M. Rohlikov, R. P. Vasilevsky, L. V. Razovа
Rok vydání: 2016
Předmět:
Zdroj: Andrologiâ i Genitalʹnaâ Hirurgiâ, Vol 17, Iss 4, Pp 59-67 (2017)
ISSN: 2412-8902
2070-9781
DOI: 10.17650/2070-9781-2016-17-4-59-67
Popis: Маterials and methods. The study hereunder was an open multicenter surveillance non-intervention study at men with testosterone deficiency, apllying daily 1 % testosterone gel (Аndrogel®) in the dosage of 50 or 100 mg (with possible titration) in terms of routine clinical practice. The initial end point was the life quality, referred to the health status, evaluated at the filling of the questionnaire on Aging Males’ Symptoms (AMS). As secondary end points served changes of the total score of the International Erectile Function Index (IEFE) and its domains, changes of body weight index (BWI) and of the waist circumference, correlation of changes in life quality indices, determined with AMS questionnaire, with laboratory indices of the testosterone level and of the data by the IEFE scale, demographic features, as well as original characteristics of patients, anamnesis of diagnostic and therapeutic procedures, reason for the treatment termination and any adverse effects, arising in the course of treatment with Androgel®. Results. The data on 196 of 202 patients, included in studies, was available for processing after 6 months of monitoring. Average values of the total testosterone level in beginning of studies were 10.8 ± 0.3 (95 % confidence interval (CI) 10.2–11.4) nmol/l after 6 months of therapy – 21.1 ± 0.4 (95 % CI 20.4–21.9) nmol/l. Significant changes were marked on the AMS scale, the average point at the 1st visit was 47.4 ± 1.0 (95 % CI 45.5–49.4), аnd at the 4th – 27.5 ± 0.8 (95 % CI 25.9–29.1); by IEFE scale at the 1st visit – 33.0 ± 1.0 (95 % CI 31.0–35.0), at the 4th – 54.0 ± 1.0 (95 % CI 52.0–57.0). Additional positive effects were marked as to BWI and the waist circumference – decrease of indices by 1,2 kg/m2 and 5 сm accordingly. Conclusion. Studies have shown the authentic reduction of expressed symptoms of testosterone deficiency, improvement of the life quality indices and of the sexual function. During 6 months of monitoring no clinically significant adverse effects were revealed.
Databáze: OpenAIRE