Comparison of intravaginal 6.5 mg (0.50%) prasterone, 0.3 mg conjugated estrogens and 10 μg estradiol on symptoms of vulvovaginal atrophy.

The objective is to compare the effect of intravaginal dehydroepiandrosterone (DHEA, prasterone), conjugated equine estrogens (CEE) and estradiol (E 2 ) on moderate to severe dyspareunia and/or vaginal dryness. In a review of available data, independent prospective, randomized, double-blind and placebo-controlled Phase III 12-week clinical trials involved daily administration of 6.5 mg (0.50%) prasterone, daily (21 days on/7 days off) 0.3 mg CEE, twice weekly 0.3 mg CEE or 10 μg E 2 daily for 2 weeks followed by twice weekly for 10 weeks. Vulvovaginal atrophy (VVA) symptoms were evaluated by questionnaires. The total severity score of dyspareunia decreased from baseline by 1.27 to 1.63 units with prasterone treatment, 1.4 with CEE and 1.23 in one statistically significant study with E 2 (combined symptoms). Decreases over placebo ranged from 0.35 to 1.21 with prasterone, 0.7 to 1.0 with CEE and 0.33 for the E 2 study. The total decreases in vaginal dryness severity ranged from 1.44 to 1.58 units for prasterone, 1.1 unit for CEE and 1.23 unit for E 2 . The decreases over placebo of vaginal dryness intensity ranged from 0.30 to 0.43 unit for prasterone, 0.40 unit for CEE and 0.33 for the E 2 study with combined symptoms. Daily 6.5 mg (0.50%) prasterone appears to be at least as efficacious as 0.3 mg CEE or 10 μg E 2 for treatment of the VVA symptoms. In summary, the beneficial effects on the VVA symptomatology can be obtained by the addition of a small amount of intravaginal prasterone to compensate for the low serum concentration of prasterone observed in the majority of women after menopause without concerns about systemic effects. [ABSTRACT FROM AUTHOR]