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

Phase 3

Conditions: Volvaginal symptoms of menopause.
Postmenopausal atrophic vaginitis
N95.2

Registration Number: IRCT20220516054881N1

Lead Sponsor: Kashan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 66

Inclusion Criteria

The patient is menopausal
Pap smears have been normal for the last 3 years
She has symptoms of vaginal atrophy
Vaginal maturity index should be less than or equal to 55
Vitamin D levels should be less than or equal to 30
The minimum entry age is 45 years and the maximum age is 65 years

Exclusion Criteria

She has a vaginal infection
She has genital abnormalities
She has a history of taking sex hormones during the 8 weeks before the study
She may have vaginal bleeding of unknown cause
She has a history of consuming a lot of phytoestrogens such as soy, red clover, fenugreek and Vitex in the past month

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal cell maturation index. Timepoint: At the beginning of the study, 8 weeks after taking the drug. Method of measurement: Vaginal cytology.;Vitamin D levels. Timepoint: The beginning of the study. Method of measurement: Blood test.;Vaginal dryness. Timepoint: The beginning of the study, day 28 and day 56. Method of measurement: Questionnaire and Likert scale.;Vaginal burning. Timepoint: The beginning of the study, day 28 and day 56. Method of measurement: Questionnaire and Likert scale.;Vaginal itching. Timepoint: The beginning of the study, day 28 and day 56. Method of measurement: Questionnaire and Likert scale.;Disparony. Timepoint: The beginning of the study, day 28 and day 56. Method of measurement: Questionnaire and Likert scale.;Abnormal vaginal discharge. Timepoint: The beginning of the study, day 28 and day 56. Method of measurement: Questionnaire and Likert scale.

Secondary Outcome Measures