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IRCT20160602028220N2 IRCT 2018-02-09 Ahvaz University of Medical Sciences The effect of Oxytocin on Vaginal Atrophy and Sexual Function in Post-menopausal Women The effect of Oxytocin Vaginal Gel on Vaginal Atrophy and Sexual Function in Post-menopausal Women 2018-02-19 anticipated 96 Complete https://irct.ir/trial/28338 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be done a non-probabilistic manner. The method of assigning medication and placebo to patients is randomized and randomized blocks with block size 4(using a random permutation table). A randomized list provide by a statistician. In this study, medication and placebo will be placed in the closed envelopes according to the randomized list and different codes by the person outside the study then assigned to any patient that enter the study. Medication and placebo are identical in appearance, packaging, color. The nature of the medication and placebo are apparenc after the analysis of the results, Blinding description: In this study, Researcher and Participating will be unware of oxytocin gel or placebo and the pharmacist will fill the oxytocin gel or placebo tubes. For this purpose, the medication and placebo will be placed in closed envelopes according to the randomized list and different codes by a person outside the study then assigned to any patient that enter the study. Medication and placebo are identical in appearance, packaging, color. The nature of the medication and the placebo will be appear after the analysis of the results.The will be explored about the purpuse of study to participants, but will be reminded them that identical and random their placement in each of the groups. 3 Vaginal atrophy and sexual function of postmenopausal women. Intervention 1: Intervention group: after the preparation of the oxytocin powder, by the trusted pharmacist Ahvaz University of Medical Sciences will be made oxytocin vaginal gel 400 IU and will be given to the intervention group that used for vaginal each night for 8 weeks.They will be asking that they visit on days 14 and 56 after treatment to recheck and follow-up.That will be completed a checklist and FSFI questionnaire and the will be done clinical and laboratory investigation. Vaginal smear and measure the ph of the vagina will be conducted in just the first and last day of the visit and other assessments will be repeated each time the examination. Intervention 2: Control group: by the trusted pharmacist Ahwaz University of medical sciences will be made placebo vaginal gel 400 units from starch and other inert materials with the appearance is quite similar to the drug and appropriate conditions and that will be given to the intervention group that used for vaginal each night for 8 weeks.They will be asking that they visit on days 14 and 56 after treatment to recheck and follow-up.That will be completed a checklist and FSFI questionnaire and the will be done clinical and laboratory investigation. Vaginal smear and measure the ph of the vagina will be conducted in just the first and last day of the visit and other assessments will be repeated each time the examination. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Ilnaz Zohrabi
Ahvaz Jundishapur University of Medical Science and Health Services, Golestan BLV, Ahvaz
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8331 zohrabi.i@ajums.ac.ir Ahvaz University of Medical Sciences scientific Ilnaz Zohrabi
Ahvaz Jundishapur University of Medical Science and Health Services, Golestan BLV, Ahvaz
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8331 zohrabi.i@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Have reading and writing skills Women aged 40-60 Passing for at least one year from the last menstruation or having a hormonal test with FSH of more than 40 international units The presence of vaginal atrophy Sexual performance score less than or equal to 26/5 Have sex and monogamy 40 years 60 years Female vaginal infection Treatment with HRT or taking sex hormones during 8 weeks before study Any major disease genital Consuming Smoking, alcohol or any opiate Uterine bleeding and spotting Body mass index more than 30 Breast disease with unknown cause Use of vaginal drugs or any lubricant for at least 15 days before the study N95.2 Postmenopausal atrophic vaginitis Treatment - Surgery Placebo Intervention group: after the preparation of the oxytocin powder, by the trusted pharmacist Ahvaz University of Medical Sciences will be made oxytocin vaginal gel 400 IU and will be given to the intervention group that used for vaginal each night for 8 weeks.They will be asking that they visit on days 14 and 56 after treatment to recheck and follow-up.That will be completed a checklist and FSFI questionnaire and the will be done clinical and laboratory investigation. Vaginal smear and measure the ph of the vagina will be conducted in just the first and last day of the visit and other assessments will be repeated each time the examination. Control group: by the trusted pharmacist Ahwaz University of medical sciences will be made placebo vaginal gel 400 units from starch and other inert materials with the appearance is quite similar to the drug and appropriate conditions and that will be given to the intervention group that used for vaginal each night for 8 weeks.They will be asking that they visit on days 14 and 56 after treatment to recheck and follow-up.That will be completed a checklist and FSFI questionnaire and the will be done clinical and laboratory investigation. Vaginal smear and measure the ph of the vagina will be conducted in just the first and last day of the visit and other assessments will be repeated each time the examination. Symptoms of vaginal atrophy. Timepoint: At the beginning of the intervention and 14 and 56 days after the start of the intervention. Method of measurement: The combined questionnaire vaginal atrophy symptoms. The percentage of the maturity of the cells of the vagina. Timepoint: before and after intervention. Method of measurement: Vaginal smears. The acidity of the vagina. Timepoint: before and after intervention. Method of measurement: PH strip. Sexual function. Timepoint: before and after intervention. Method of measurement: Female sexual function index questionnaire. Ahvaz University of Medical Sciences Approved 2017-11-10 Ethics Committee of Ahvaz JundiShapur University of Medical Sciences and Health Services Ahvaz Jundishapur University of Medical Science and Health Services, Golestan BLV, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)