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IRCT20151123025202N10 IRCT 2020-06-22 Hamedan University of Medical Sciences Treatment of postmenopausal genital syndrome Comparison of the therapeutic effect of conjugated estrogen vaginal cream with vitamin D and E combination vaginal cream in the treatment of postmenopausal genital syndrome 2020-07-21 anticipated 64 Complete https://irct.ir/trial/49066 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We made 64 cards and write letter I on 32 for Intervention and on the other 32 letter C for the control group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and will be opened, based on selected letter ( I or C) patients will be assigned to intervention or control group, Blinding description: Vaginal creams will be in prepared in two different colors.Neither the patients nor the prescribing physician will be aware of the active ingredient in the cream.When analyzing data, group code is revealed. 3 Genital urinary syndrome in postmenopausal women. Intervention 1: Intervention group: This group will be treated with a combination vaginal cream containing Vitamin D 1000 IU / dose and Vitamin E 100 IU / dose once a day for 2 weeks and followed by three times a week for 10 weeks. Intervention 2: Control group: Patients in this group will be treated with 0.625 g / dose estrogen conjugated vaginal cream (1 gram of estrogen produced by Abu Reihan Pharmaceutical Company, equivalent to a quarter of a 4 g applicator) once a day for 2 weeks and followed by three times a week for 10 weeks. 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 Abbas Moradi
Shahid Fahmideh Ave
Hamedan Iran (Islamic Republic of) 6517838736 +98 81 3838 0097 a.moradi@umsha.ac.ir Hamedan University of Medical Sciences scientific Dr Nahid Radnia
Pasdaran Ave
Hamedan Iran (Islamic Republic of) 6517789971 +98 81 1827 7459 n.radnia@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) postmenopausal women Has urinary-genital symptoms: vaginal itching, burning, dryness, dyspareunia, urination frequency and burning 45 years no limit Female Definitely or suspected of having endometrial or breast cancer Women with abnormal vaginal bleeding or vaginal infection Women with Diabetes, CKD, Arthritis, Cardiovascular Disease and Active Hepatobiliary Disease Sensitivity to vitamin E, D or vaginal estrogen Women have spouses with sexual dysfunction Women who have been on hormone therapy for the past 12 weeks N95 Menopausal and other perimenopausal disorders Treatment - Drugs Treatment - Drugs Intervention group: This group will be treated with a combination vaginal cream containing Vitamin D 1000 IU / dose and Vitamin E 100 IU / dose once a day for 2 weeks and followed by three times a week for 10 weeks Control group: Patients in this group will be treated with 0.625 g / dose estrogen conjugated vaginal cream (1 gram of estrogen produced by Abu Reihan Pharmaceutical Company, equivalent to a quarter of a 4 g applicator) once a day for 2 weeks and followed by three times a week for 10 weeks Changes in urinary-genital symptoms. Timepoint: Week 4, 12 and 16 after treatment onset. Method of measurement: Get a history and clinical examination. Marital Quality of life. Timepoint: 16 weeks after treatment onset. Method of measurement: Women's Sexual Performance Index Questionnaire. Hamedan University of Medical Sciences Approved 2020-05-22 Ethics committee of Hamadan Univercity of Medical Science Shahid Fahmideh Avenue Hamedan Hamadan Iran (Islamic Republic of)