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IRCT20200215046494N1 IRCT 2020-03-22 Gonabad University of Medical Sciences The effect of Citrus aurantium on vaginal atrophy The effect of Citrus aurantium vaginal cream on vaginal atrophy in postmenopausal women 2020-04-18 anticipated 30 Complete https://irct.ir/trial/46332 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Vaginal atrophy. Citrus aurantium vaginal cream 4%, one applicator every night for two weeks and then one night in between in later two-weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participant information is confidential
public Mahram Asgharpoor
Asian Roadside , Gonabad University of Medical Sciences
Gonabad Iran (Islamic Republic of) 9691793718 +98517223028 homeira_60@yahoo.com Gonabad University of Medical Sciences scientific Fatemeh hadizadeh -Talasaz
Asian Roadside , Gonabad University of Medical Sciences
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3028 shahnazhadizadeh@yahoo.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Having amenorrhea for at least 12 months Age 45-65 years old Having sex with single spouse Normal Pap smear over the past 3 years Body mass index less than 30 Complaining of vaginal atrophy symptoms (vaginal burning, vaginal itching , Vaginal dryness and pain during intercourse) Getting a score of ≥ 65 on the visual analogue scale (VAS) Having at least one symptom of vaginal mucosa descriptive evaluation table symptoms pH value > 5 Vaginal maturation value (VMV) < 50 45 years 65 years Female Vaginal infection or any other important genital tract disease (sexually transmitted diseases) Excessive consumption of phytoestrogens such as soy, red clover, fenugreek and vitex during the 8 weeks prior to the study Use of hormone replacement therapy during the 8 weeks before the study A history of asthma and allergies to certain herbs or citrus fruits Use of vaginal drugs or any lubricant for at least 15 days prior to study Smoking, alcohol or any other drug Mammary mass Uterine bleeding or spotting Kidney Disorders, Kidney Failure, Hypertension, Thyroid Disorders, Liver Disorders, Heart Problems, Psychological problems and epilepsy Use of monoamine oxidase drugs, antidepressants, Antihypertensive drugs, thyroid medication, supplements and vitamins Prolapse of pelvic organs grade 3 or More N95.2 Postmenopausal atrophic vaginitis Treatment - Drugs Citrus aurantium vaginal cream 4%, one applicator every night for two weeks and then one night in between in later two-weeks Vaginal acidity. Timepoint: Before and 2 and 4 weeks after intervention. Method of measurement: pH strip. Vaginal maturation value. Timepoint: Before and 2 and 4 weeks after intervention. Method of measurement: Vaginal smear. Subjective symptoms of vaginal atrophy. Timepoint: Before and 2 and 4 weeks after intervention. Method of measurement: Visual Analogue Scale. Vaginal physical examination. Timepoint: Before and 2 and 4 weeks after intervention. Method of measurement: Vaginal physical examination checklist. Quality of life. Timepoint: Before and 2 and 4 weeks after intervention. Method of measurement: Menopause quality of life questionnaire (MENQOL questionare). Gonabad University of Medical Sciences Approved 2020-01-14 Ethics committee of Gonabad University of Medical Sciences Asian Road Margin, Gonabad University of Medical Sciences Gonabad Razavi Khorasan Iran (Islamic Republic of)