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

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

Phase 3 Randomized Clinical trial on 64 patients. samples will be randomly assigned to two intervention and control groups.

This double blind study will be conducted in Fatemieh Hospital affiliated to Hamadan University of Medical Sciences. In this study, the coverage of the ointments will be made in different colors, the prescribing physician and the patient will be unaware of the content inside them.

Participants are postmenopausal women with genital urinary syndrome include vaginal dryness, burning and itching of the vagina, dyspareunia, and urinary symptoms of burning and frequent urination. Conditions for not entering the study include: definitive or suspected endometrial or breast cancer, abnormal vaginal bleeding or vaginal infection, a history of diabetes, CKD, arthritis, cardiovascular disease and active hepatobiliary disease, sensitivity to vitamin E, D or estrogen. women who have had hormone therapy for the past 12 weeks and women whose husbands have a sexual dysfunction.

In the intervention group, patients will be treated with a combination vaginal cream containing Vitamin D 1000 IU / dose and Vitamin E 100 IU / dose with daily once a day for 2 weeks and then three times a week for 10 weeks. In the control group, patients will be treated with 0.625 g / dose estrogen conjugated vaginal cream (1 g of estromarin produced by Abu Reihan Pharmaceutical Company, equivalent to a quarter of a 4 g applicator) once a day for 2 weeks, followed by three times a week for 10 weeks.

Primary outcome of study will be changes in genital urinary symptoms and secondary outcome patients' marital quality of life.

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.

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.