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IRCT20181027041473N1 IRCT 2019-01-09 Mashhad University of Medical Sciences The comparison the effect of flaxseed and Conjugated Estrogen vaginal cream in vaginal atrophy and sexual satisfaction of postmenopausal women. The comparison the effect of flaxseed and Conjugated Estrogen vaginal cream in vaginal atrophy and sexual satisfaction of postmenopausal women. 2018-11-22 anticipated 70 Complete https://irct.ir/trial/34937 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization by using spss software is done, Blinding description: In comparison, the control and intervention groups of their vaginal cream flaxseed and estrogen were apparently identical, therefore, the sample case and evaluators, analysts and sample allocators are blind to the groups. 3 atrophy and sexual satisfaction. Intervention 1: Control group: use conjugated estrogen vaginal cream for 8 weeks, so that the first two weeks every night, then twice a week until the end of the study period. Intervention 2: Intervention group: Use flaxseed vaginal cream for 8 weeks so that the first two weeks every night once, then twice a week until the end of the study period. 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 there is no more information
public Fahimeh shakeri
faculty of Nursing and Midwifery, Ebnesina Ave.
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Shakerif961@mums.ac.ir Mashhad University of Medical Sciences scientific Nahid Golmakani
Faculty of Nursing and Midwifery, Ebnesina Ave.
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 GolmakaniN@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having a willingness to participated in the study Married and have sexual activity age range of 40-65 years Have literacy to read and write Amenorrhoea has been followed for at least 12 months or 6 months amenorrhoea with FSH> 40. Have normal Pap smear in the past 3 years Clinic diagnosis of vaginal atrophy through a set of criteria including: score 65 or more (based on the VAS visual criteria) of the scale of the most vaginal annoyance symptoms (MBS) and having at least 2 signs of the descriptive evaluation table of vaginal mucus, PH> 5 and VMV≤55 (vaginal maturation grade). 40 years 65 years Female Abnormal bleeding vaginal (pink to brown spotting or clear bleeding). have chronic illness such as diabetes, arthritis, cardiovascular disease, active liver disease or gallbladder disease. having vaginal infection allergy to estrogen or flax seed compounds don't suffering of endometrial cancer or breast cancer Endometrial cancer or breast cancer known or suspected . Consumer Products hormonal vaginal or transdermal than 4 weeks prior to the study and use of oral estrogen, uterine progesterone 8 weeks before the study and use of implants progesterone and estrogen injections for 3 months and pellets of estrogen and progesterone injections 6 months prior to the study to be N95.2 Postmenopausal atrophic vaginitis Treatment - Drugs Treatment - Drugs Control group: use conjugated estrogen vaginal cream for 8 weeks, so that the first two weeks every night, then twice a week until the end of the study period Intervention group: Use flaxseed vaginal cream for 8 weeks so that the first two weeks every night once, then twice a week until the end of the study period Atrophy and sexual satisfaction treatment. Timepoint: Performing the intervention then measuring vaginal atrophy and sexual satisfaction in the fourth and eighth weeks. Method of measurement: Using vaginal maturation index of more than 55 and a vaginal pH of more than 5 and gaining a score of 65 or more from the scale of the most vaginal annoying symptoms and having at least two signs of the symptoms of a descriptive evaluation table of vaginal mucus. Mashhad University of Medical Sciences Approved 2018-10-21 Ethics committee of Mashhad University of Medical Sciences Quraishi Building, university street, Mashhad. Mashhad Razavi Khorasan Iran (Islamic Republic of)