Pulsed estrogen therapy improves postmenopausal quality of life: a 2-year placebo-controlled study.

Objective: To investigate the effect of pulsed estrogen therapy S21400 (intranasal 17 beta-estradiol) on different quality of life (QoL) dimensions in early postmenopausal women treated with S21400 150 microg per day, S21400 300 microg per day, or placebo in a double blind, randomized, controlled 2-year study.

Study Design: QoL was assessed based on the validated Women's Health Questionnaire designed for peri- and post-menopausal women. Three hundred and thirty-five healthy, early postmenopausal Danish women, 53 years of age in average, who completed one questionnaire at baseline and one under study treatment were included in the analysis set. All analyses were performed on an intention-to-treat basis.

Results: QoL improved significantly in both S21400 groups compared to placebo in the dimensions 'memory/concentration', 'vasomotor symptoms', 'sleep problems' and 'sexual behavior' (difference in mean change scores being respectively +7.9, +28.3, +9.9 and +10.8%, p < 0.001, between the S21400 300 microg and placebo group). There were no significant differences between actively treated groups and placebo in the dimensions 'anxiety/depressed mood' and 'well-being'.

Conclusion: Pulsed estradiol therapy had a pronounced effect not only on vasomotor symptoms but also a significant and clinically relevant improvement in several other QoL dimensions.