Sonia M Rolim Rosa Lima1, Silvia Saito Yamada1, Benedito Fabiano Reis2, Sostenes Postigo1, Maria Antonieta L Galvão da Silva3, Tsutomu Aoki1. 1. Department of Gynecology and Obstetrics, Santa Casa of Sao Paulo Medical School, Sao Paulo, Brazil. 2. Department of Gynecology and Obstetrics, Santa Casa of Sao Paulo Medical School, Sao Paulo, Brazil; Department of Gynecology and Obstetrics, Vale do Sapucaí University, Pouso Alegre, Minas Gerais, Brazil. Electronic address: benefabiano@uol.com.br. 3. Department of Pathology, Santa Casa of Sao Paulo Medical School, Sao Paulo, Brazil.
Abstract
OBJECTIVE: To assess efficacy and tolerability of a isoflavone (Glycine max L. Merr.) vaginal gel to the treatment of vaginal atrophy in postmenopausal women. METHODS: The double-blind, randomized, placebo-controlled, clinical trial. Ninety women were treated for 12 weeks withisoflavone vaginal gel 4% (1g/day) and a placebo gel and conjugated equine estrogen cream (0.3mg/day). After 4 and 12 weeks, the vaginal atrophy symptoms were classified at none, mild, moderate and severe and the vaginal cytology were taken to determine the maturation value. The endometrial safety (by transvaginal ultrasonography) was evaluated through at screening and the end of the trial. RESULTS:Isoflavone vaginal gel appears to be effective for relief of vaginal dryness and dyspareunia symptoms and an increase in the intermediate and superficial cells was noted. These results were similar to the effects with use of conjugated equine estrogens and superior to placebo gel. No changes in endometrial thickness, sera FSH and estradiol levels were observed at study endpoint. CONCLUSION:Glycine max (L.) Merr. at 4% vaginal gel on a daily basis in postmenopausal women led to improvements in vaginal atrophy symptoms and a significant increase in cell maturation values. Isoflavones proved good treatment options for relief of vulvovaginal symptoms especially in women who do not wish to use hormonal therapy or have contra-indications for this treatment.
RCT Entities:
OBJECTIVE: To assess efficacy and tolerability of a isoflavone (Glycine max L. Merr.) vaginal gel to the treatment of vaginal atrophy in postmenopausal women. METHODS: The double-blind, randomized, placebo-controlled, clinical trial. Ninety women were treated for 12 weeks with isoflavone vaginal gel 4% (1g/day) and a placebo gel and conjugated equine estrogen cream (0.3mg/day). After 4 and 12 weeks, the vaginal atrophy symptoms were classified at none, mild, moderate and severe and the vaginal cytology were taken to determine the maturation value. The endometrial safety (by transvaginal ultrasonography) was evaluated through at screening and the end of the trial. RESULTS:Isoflavone vaginal gel appears to be effective for relief of vaginal dryness and dyspareunia symptoms and an increase in the intermediate and superficial cells was noted. These results were similar to the effects with use of conjugated equine estrogens and superior to placebo gel. No changes in endometrial thickness, sera FSH and estradiol levels were observed at study endpoint. CONCLUSION:Glycine max (L.) Merr. at 4% vaginal gel on a daily basis in postmenopausal women led to improvements in vaginal atrophy symptoms and a significant increase in cell maturation values. Isoflavones proved good treatment options for relief of vulvovaginal symptoms especially in women who do not wish to use hormonal therapy or have contra-indications for this treatment.