Comparison of the effect of vitamins D and E with conjugated estrogen vaginal cream on menopausal vulvovaginal symptoms

Comparison of the effect of vitamins D and E with conjugated estrogen vaginal cream on menopausal vulvovaginal symptoms

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 66 patients, randomization list through www. sealedenvelope.com/simple-randomiser/v1/lists

After referring to the clinic of Shahid Beheshti Hospital in Kashan, in the first visit, 22 people will be given vitamin D500000, 22 others will be given 400 IU vitamin E capsules and 22 others will be given conjugated estrogen vaginal cream. They will consume it daily for two months. The necessary instructions on how to use the drug daily in an applicator for 14 days and then twice a week, will be given deep inside the vagina before going to bed and the patient will be given a daily record of drug use. All three groups receive the same drugs in the same package, size and box. The codes remain with one of the research project colleagues and will be decoded at the end of the study. None of the administrators and patients know the type of codes of each patient until after analyzing the data

Postmenopausal women 45 to 65 years with vulvovaginal menopausal symptoms

Three intervention groups have been identified: 1- Take vitamin D supplement - Perl 50,000 weekly 2- Receiving vitamin E supplement - IU400 capsule daily 3- Receiving conjugated vaginal cream - daily, one applicator for 14 days and then twice a week, deep inside the vagina

Vaginal dryness, vaginal irritation, vaginal itching, dyspareunia, abnormal vaginal discharge, vaginal cell maturity index and vitamin D levels

The randomization method will be: first, the group receiving vitamin D with the letter A, the group receiving vitamin E with the letter B and the group receiving conjugated estrogen with the letter C, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists The randomization list will be prepared by selecting a sample size of 66 (3 groups of 22) and a balanced 6-part blocking method. Then, through the obtained randomization list, the enrolled people (in the order of enrollment time) will be assigned to one of the two groups A or B or C.

All three groups receive the same drugs in the same package, size and box. The codes remain with one of the research project colleagues and will be decoded at the end of the study. None of the administrators and patients have any information about the type of codes of each patient after analyzing the data. Thus, this study is performed in two blinds.