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IRCT20150424021917N12 IRCT 2021-06-13 Tabriz University of Medical Sciences Comparison of effect of vitamin E vaginal cream with vaginal estradiole on atrophic vaginitis among menopausal women. Comparison of effect of vitamin E vaginal cream with vaginal estradiole on atrophic vaginitis among menopausal women. 2021-06-22 anticipated 72 Complete https://irct.ir/trial/56210 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, randomization will be done using random blocks size 4 and 6. Randomization will be individual randomization. For randome allocation, vitamin E vaginal cream and conjugated estrogen cream are put in opaque envelopes. On the envelopes A and B code and numbers are written. Envelops will be given to the participants respectively, Blinding description: In this study, participants, researcher and data analyzer will be blind. Each type of drugs will be the same according to smell, shape and color. the drugs will be accepted code A or B. This code is clarified only of drug formulation specialist. So the participants, researcher and data analyzer will be blind. After data analyzing formulation specialist will be clarified that each code of A and B belong to which group. 2 Atrophic Vaginitis. Intervention 1: Intervention group: vitamin E vaginal cream containing 100 IU of vitamin E in half of the applicator. The half of the vaginal cream applicator is used every night during the first week and two nights every week in the following weeks. Intervention 2: Control group: conjugated estrogen vaginal cream with a dose of 0.625 mg in half of applicator containing 0.3 mg of conjugated estrogen. The half of the vaginal cream applicator is used every night during the first week and two nights every week in the following weeks. Yes - There is a plan to make this available What will be shared: Primary and secondary outcomes, as well as side events will be distributed. When: Six months after publication of results. To whom: Records will be distributed of academic researchers and " research and development" units of pharmaceutical companies. Conditions: " Research and development" unit of each pharmaceutical companies can use of records. All requests will be evaluated after receiving formal e- mail and telephone or face to face negotiation. Where to obtain: Sevil Hakimi hakimis@tbzmed.ac.ir How to obtain: The applicant notifies the applicant by email, after receiving the email the results are sent. Comments:
public Sevil Hakimi
Faculty of Nursing & Midwifery, South Shariaty Street
Tabriz Iran (Islamic Republic of) 5138947977 +98 4134790364 - 34796770 hakimisevil@gmail.com Tabriz University of Medical Sciences scientific Sevil Hakimi
Faculty of Nursing & Midwifery, South Shariaty Street
Tabriz Iran (Islamic Republic of) 5138947977 +98 4134790364 - 34796770 hakimisevil@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Physiologic menopause women Having sexual activity Affected by atrophic vaginitis(having 3 signs out of 5 signs) Affected by over active bladder syndrome (score 3 of the OABSS questionnaire) 45 years 56 years Female Vaginal bleeding Hormone replacement therapy during last 3 months History of breast cancer or any type of estrogen dependent cancer History of breast cancer in first grade relatives (ex. mother, sister) Estrogen contraindications include a history of gallstones, a history of venous thrombosis, any type of vascular disease, the presence of thrombophlebitis. Taking anticoagulants N95.2 Senile (atrophic) vaginitis Treatment - Drugs Treatment - Drugs Intervention group: vitamin E vaginal cream containing 100 IU of vitamin E in half of the applicator. The half of the vaginal cream applicator is used every night during the first week and two nights every week in the following weeks Control group: conjugated estrogen vaginal cream with a dose of 0.625 mg in half of applicator containing 0.3 mg of conjugated estrogen. The half of the vaginal cream applicator is used every night during the first week and two nights every week in the following weeks Score of symptoms of atrophic vaginitis. Timepoint: Vaginal symptoms score will be measured before and 8 weeks after the start of the intervention. Method of measurement: For evaluation of this variable we will use of standard questionnaire. Score of symptoms of overactive bladder syndrome. Timepoint: Score of symptoms of overactive bladder syndrome will be measured before and 8 weeks after the start of the intervention. Method of measurement: A standard questionnaire is used to measure this variable. Satisfaction score. Timepoint: Satisfaction score of the drug will be measured 8 weeks after the start of the intervention. Method of measurement: A standard questionnaire is used to measure this variable. Frequency of side effects. Timepoint: frequency of side effects, will be measured 8 weeks after the start of the intervention. Method of measurement: A standard questionnaire is used to measure this variable. Tabriz University of Medical Sciences Approved 2021-05-02 Ethics committee of Tabriz University of Medical Sciences Faculty of Nursing & Midwifery, South Shariaty Street Tabriz East Azarbaijan Iran (Islamic Republic of)