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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220516054881N1

Enrollment

Registered

2022-05-25

Start date

2022-05-30

Completion date

Unknown

Last updated

2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Volvaginal symptoms of menopause. Postmenopausal atrophic vaginitis

Interventions

Intervention 1: Intervention group: Receiving pearl vitamin D with a dose of 50000 IU (Cholecalciferol) under the brand name D-vigel from Dana Pharma once a week for 8 weeks. Intervention 2: Intervent

Eligibility

Sex/Gender

Female

Age

45 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSayad Nazari

Kashan University of Medical Sciences

nazari-s@kaums.ac.ir+98 31 5510 3400

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026