Effect of Oxytocin on Postmenopausal Genital and Urinary Symptoms: Randomized and Double-Blind Study

INTERVENTION: Biopsy Drug Oxytocin Pathological Conditions, Signs and Symptoms This study was prospective, double‐blind, randomized, developed between September 2018 to January 2020. The patients were selected at the climacteric outpatient clinic of the Endocrine and Climacteric Gynecology sector at Escola Paulista de Medicina, São Paulo. Patients diagnosed with recent and spontaneous menopause (up to 5 years after the last spontaneous menstruation) and presenting symptoms or clinical signs of Menopause Genitourinary Syndrome (SGM) were selected. Inclusion criteria were: patients of any age and spontaneous menopause in the last 5 years. The non‐inclusion criteria were: patients who used hormonal therapy (herbal medicines, intrauterine device, oral estrogen, vaginal or transdermal topical) in the last 12 months or who are undergoing treatment. Exclusion criteria were: patients with a history of previous or current malignancy (breast, uterus), previous or current endometrial hyperplasia and non‐updated gynecological routine described in medical records (including annual mammogram, triennial cervical cytopathology when two previous negative results and transvaginal ultrasound with endometrial echo measurement of the last 12 months). The study selected 50 patients who comprised two distinct groups, group 1 was composed of patients who were randomized for treatment with vaginal topical oxytocin gel 300IU and group 2 for patients randomized for conventional treatment with vaginal promestriene. The selected patients visited the clinic twice during the study, the first visit being on the day of the selection, where they answered a questionnaire to quantify the symptoms they present with SGM. Topical vaginal oxytocin was prescribed by the researchers and applied by the patients in a double‐blind manner controlled by conventional treatme CONDITION: Atrophy of vulva Climacteric Climacteric; Menopause; Postmenopausal Atrophic Vaginitis; Dyspareunia; Vulva Atrophy; Postmenopausal Vaginal Dryness. ; Menopause ; Climacteric ; Postmenopausal atrophic vaginitis ; Dyspareunia ; Atrophy of vulva ; Other specified noninflammatory disorders of vagina ; Postmenopause Dyspareunia Menopause N00‐N99 Other specified noninflammatory disorders of vagina Postmenopausal atrophic vaginitis Postmenopause PRIMARY OUTCOME: Improvement of genitourinary symptoms after menopause after the use of topical vaginal oxytocin, verified through a questionnaire answered by patients before medication, 45 days after and 3 months after, symptoms including vaginal dryness, pain or discomfort during sexual intercourse and urinary frequency.; Improvement in the thickness of the vaginal epithelium after the use of topical vaginal oxytocin, epithelial thickness measured by a pathologist in the thickest site; using a Reticulum Melanoma ruler (Breslow's Ruler). SECONDARY OUTCOME: Improvement of the gynecological examination after the use of vaginal oxytocin, verified through the evaluation of the gynecologist researcher, including the parameters of vaginal color, roughness, petechiae and friability. INCLUSION CRITERIA: Spontaneous menopause in the last 5 years; any age; denial of the use of hormone therapy in the last 12 months.