Comparison of intravaginal 6.5mg (0.50%) prasterone, 0.3mg conjugated estrogens and 10μg estradiol on symptoms of vulvovaginal atrophy.
The objective is to compare the effect of intravaginal dehydroepiandrosterone (DHEA, prasterone), conjugated equine estrogens (CEE) and estradiol (E2) 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 6.5mg (0.50%) prasterone, daily (21days on/7days off) 0.3mg CEE, twice weekly 0.3mg CEE or 10μg E2daily 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 E2(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 E2study. 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 E2. 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 E2study with combined symptoms. Daily 6.5mg (0.50%) prasterone appears to be at least as efficacious as 0.3mg CEE or 10μg E2for 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.
CONRAD Clinical Research Center, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA, USA.
David F
DF
Archer
Endoceutics Inc., Quebec City, QC, Canada. Electronic address: fernand.labrie@endoceutics.com.
Fernand
F
Labrie
Endoceutics Inc., Quebec City, QC, Canada.
Marlene
M
Montesino
Endoceutics Inc., Quebec City, QC, Canada.
Céline
C
Martel
D000282:Administration, Intravaginal; D001284:Atrophy / Q000188:drug therapy*; D003687:Dehydroepiandrosterone / Q000008:administration & dosage / Q000627:therapeutic use*; D004414:Dyspareunia / Q000188:drug therapy; D004958:Estradiol / Q000008:administration & dosage / Q000627:therapeutic use*; D004967:Estrogens / Q000008:administration & dosage / Q000627:therapeutic use*; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D014621:Vagina / Q000473:pathology; D014623:Vaginal Diseases / Q000188:drug therapy*; D014844:Vulva / Q000473:pathology
D004967:Estrogens; D004966:Estrogens, Conjugated (USP); D003687:Dehydroepiandrosterone; D004958:Estradiol
Conjugated estrogens; Dehydroepiandrosterone; Dyspareunia; Estradiol; Intravaginal; Prasterone; Vaginal atrophy; Vaginal dryness