Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC 230 open label study
Abstract Objective: Intravaginal DHEA (dehydroepiandrosterone, prasterone) the exclusive precursor of androgens and estrogens in postmenopausal women, has previously been shown to improve all the domains of sexual function by a strictly local action in the vagina. The well recognized female sexual function index (FSFI) questionnaire was used in the present study. Design: The long term effect of 52 week treatment with daily intravaginal 0.50% (6.5 mg) DHEA was evaluated on the various domains of female sexual function using the FSFI questionnaire at baseline, Week 26 and Week 52. Subjects: One hundred and fifty four postmenopausal women with at least one mild to severe symptom of vulvovaginal atrophy (VVA) and who have completed the FSFI questionnaire at baseline and at least one post baseline timepoint were included in the analysis. Results: The FSFI domains desire, arousal, lubrication, orgasm, satisfaction and pain were increased by 28% 49% 115% 51% 41% and 108% respectively (p<0.0001 for all parameters) at 52 weeks vs. baseline, while the total score was increased from 13.4+ 0.62 at baseline to 21.5+ 0.82 +60% p<0.0001) at 52 weeks. Conclusion: As the serum levels of DHEA and all its metabolites, including estradiol and testosterone, show no meaningful change, the present clinical data indicate a stimulatory effect of intravaginal DHEA through a strictly local action in agreement with the preclinical data showing that the androgens made locally from DHEA in the vagina induce an increase in local nerve density.
Hormone molecular biology and clinical investigation