AIM: To evaluate with validated instruments changes in quality of life and sexuality in women receiving hormonal replacement therapy (AHT). DESIGN: Randomised, double-blind, double-dummy study with two parallel treatment arms. PATIENTS AND METHODS: Forty-seven healthy post-menopausal women, aged 45-64 years, were evaluated using the Female Sexual Function Index (FSFI) and the menopause-specific quality of life questionnaire (MENQOL). Of them, 40 diagnosed with sexual dysfunction were randomised (1:1) to receive daily 0.625 mg of conjugated estrogens plus 1.25 mg of methyl-testosterone and 100 mg of micronised progesterone or placebo. After 3 months follow-up, FSFI and MENQOL questionnaires were administered for a second time. RESULTS:Quality of life was unchanged in the placebo group whereas AHT significantly improved scores of vasomotor, psychological, physical and sexual symptoms. As expected, FSFI was not modified in the placebo group while in AHT group the FSFI score improved significantly. In addition, at the end of the study, 68.7% of subjects of the AHT group did not fit did not fit the criteria for sexual dysfunction as per the FSFI (p < 0.0001). CONCLUSIONS: Adding methyl-testosterone to hormone therapy improves quality of life and sexuality in post-menopausal women with sexual dysfunction.
RCT Entities:
AIM: To evaluate with validated instruments changes in quality of life and sexuality in women receiving hormonal replacement therapy (AHT). DESIGN: Randomised, double-blind, double-dummy study with two parallel treatment arms. PATIENTS AND METHODS: Forty-seven healthy post-menopausal women, aged 45-64 years, were evaluated using the Female Sexual Function Index (FSFI) and the menopause-specific quality of life questionnaire (MENQOL). Of them, 40 diagnosed with sexual dysfunction were randomised (1:1) to receive daily 0.625 mg of conjugated estrogens plus 1.25 mg of methyl-testosterone and 100 mg of micronised progesterone or placebo. After 3 months follow-up, FSFI and MENQOL questionnaires were administered for a second time. RESULTS: Quality of life was unchanged in the placebo group whereas AHT significantly improved scores of vasomotor, psychological, physical and sexual symptoms. As expected, FSFI was not modified in the placebo group while in AHT group the FSFI score improved significantly. In addition, at the end of the study, 68.7% of subjects of the AHT group did not fit did not fit the criteria for sexual dysfunction as per the FSFI (p < 0.0001). CONCLUSIONS: Adding methyl-testosterone to hormone therapy improves quality of life and sexuality in post-menopausal women with sexual dysfunction.