OBJECTIVES: Intravaginal testosterone has emerged as a potential treatment for vulvovaginal atrophy (VVA) in women, in general, and women taking an aromatase inhibitor (AI). A systematic review of the literature was undertaken to determine whether available clinical trial data support efficacy and safety of intravaginal testosterone for the treatment of VVA. METHODS: Scopus, MEDLINE, EMBASE, and the Cochrane Library databases were systematically searched on July 26, 2017, for human studies published in English of clinical trials of intravaginal testosterone. RESULTS: Six separate clinical trials were identified that ranged in size from 10 to 80 participants, with either single dose, or durations of 4 to 12 weeks. Only one study incorporated a double-blind design. Three studies were of women taking an AI.Taken together, the studies suggest that intravaginal testosterone may lower vaginal pH, increase the proportion of vaginal lactobacilli, and possibly improve the vaginal maturation index. The lack of a placebo treatment in four studies, and failure to adjust for baseline differences, resulted in uncertainty of the effect on sexual function. Safety remains uncertain because of the small number of women exposed, short study durations, and inconsistent and incomplete outcome reporting for sex steroid levels. CONCLUSION: Adequately powered double-blind, placebo-controlled clinical trials of intravaginal testosterone therapy are needed to establish both efficacy and safety.
OBJECTIVES: Intravaginal testosterone has emerged as a potential treatment for vulvovaginal atrophy (VVA) in women, in general, and women taking an aromatase inhibitor (AI). A systematic review of the literature was undertaken to determine whether available clinical trial data support efficacy and safety of intravaginal testosterone for the treatment of VVA. METHODS: Scopus, MEDLINE, EMBASE, and the Cochrane Library databases were systematically searched on July 26, 2017, for human studies published in English of clinical trials of intravaginal testosterone. RESULTS: Six separate clinical trials were identified that ranged in size from 10 to 80 participants, with either single dose, or durations of 4 to 12 weeks. Only one study incorporated a double-blind design. Three studies were of women taking an AI.Taken together, the studies suggest that intravaginal testosterone may lower vaginal pH, increase the proportion of vaginal lactobacilli, and possibly improve the vaginal maturation index. The lack of a placebo treatment in four studies, and failure to adjust for baseline differences, resulted in uncertainty of the effect on sexual function. Safety remains uncertain because of the small number of women exposed, short study durations, and inconsistent and incomplete outcome reporting for sex steroid levels. CONCLUSION: Adequately powered double-blind, placebo-controlled clinical trials of intravaginal testosterone therapy are needed to establish both efficacy and safety.