H A Torky1, A Taha2, H Marie3, E El-Desouky2, O Raslan2, A A Moussa2, A M Ahmad4, A Abo-Louz1, S Zaki3, T Fares2, A Eesa5. 1. a Department of Obstetrics and Gynecology , October 6th University , Cairo , Egypt. 2. b Department of Obstetrics and Gynecology , Al-Azhar University , Cairo , Egypt. 3. c Department of Obstetrics and Gynecology , Cairo University , Cairo , Egypt. 4. d Department of Obstetrics and Gynecology , Al-Galaa Teaching Hospital , Cairo , Egypt. 5. e Department of Pathology , Cairo University , Cairo , Egypt.
Abstract
OBJECTIVE AND DESIGN: Prospective randomized controlled trial to test the effectiveness of topical oxytocin gel to improve vaginal atrophy in postmenopausal women. PATIENTS AND METHODS: A total of 140 postmenopausal women presenting with vaginal atrophy and who satisfied the inclusion and exclusion criteria were randomized into two groups each of 70 patients; they received intravaginal oxytocin gel or placebo gel for 30 days. Serum estrogen level, visual, colposcopic and histological vaginal examination were performed before and after treatment. RESULTS: Forty-seven out of 70 women in the oxytocin gel group improved after treatment and none in the placebo group (p = 0.001). Forty-five participants in the oxytocin group and seven in the placebo group reported relief of dyspareunia (p = 0.001). Thirty-four participants in the oxytocin group and seven in the placebo group reported relief of soreness (p = 0.001). There was no significant difference between the circulating levels of estradiol in both groups before and after treatment (p = 0.4 and 0.6 for the oxytocin group and the placebo group, respectively). CONCLUSION:Oxytocin gel is useful in the restoration of the vaginal epithelium in cases of postmenopausal atrophic vaginitis. Further studies with a longer follow-up period are required to test the long-term effects of oxytocin as a treatment for vaginal atrophy.
RCT Entities:
OBJECTIVE AND DESIGN: Prospective randomized controlled trial to test the effectiveness of topical oxytocin gel to improve vaginal atrophy in postmenopausal women. PATIENTS AND METHODS: A total of 140 postmenopausal women presenting with vaginal atrophy and who satisfied the inclusion and exclusion criteria were randomized into two groups each of 70 patients; they received intravaginal oxytocin gel or placebo gel for 30 days. Serum estrogen level, visual, colposcopic and histological vaginal examination were performed before and after treatment. RESULTS: Forty-seven out of 70 women in the oxytocin gel group improved after treatment and none in the placebo group (p = 0.001). Forty-five participants in the oxytocin group and seven in the placebo group reported relief of dyspareunia (p = 0.001). Thirty-four participants in the oxytocin group and seven in the placebo group reported relief of soreness (p = 0.001). There was no significant difference between the circulating levels of estradiol in both groups before and after treatment (p = 0.4 and 0.6 for the oxytocin group and the placebo group, respectively). CONCLUSION:Oxytocin gel is useful in the restoration of the vaginal epithelium in cases of postmenopausal atrophic vaginitis. Further studies with a longer follow-up period are required to test the long-term effects of oxytocin as a treatment for vaginal atrophy.