Comparison of effect of vitamin E vaginal cream with vaginal estradiole on atrophic vaginitis among menopausal women.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150424021917N12

Enrollment

Registered

2021-06-13

Start date

2021-06-22

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Atrophic Vaginitis. Senile (atrophic) vaginitis

Interventions

Intervention 1: Intervention group: vitamin E vaginal cream containing 100 IU of vitamin E in half of the applicator. The half of the vaginal cream applicator is used every night during the first wee

Eligibility

Sex/Gender

Female

Age

45 Years to 56 Years

Inclusion criteria

Inclusion criteria: Physiologic menopause women Having sexual activity Affected by atrophic vaginitis(having 3 signs out of 5 signs) Affected by over active bladder syndrome (score 3 of the OABSS questionnaire)

Exclusion criteria

Exclusion criteria: Vaginal bleeding Hormone replacement therapy during last 3 months History of breast cancer or any type of estrogen dependent cancer History of breast cancer in first grade relatives (ex. mother, sister) Estrogen contraindications include a history of gallstones, a history of venous thrombosis, any type of vascular disease, the presence of thrombophlebitis. Taking anticoagulants

Design outcomes

Primary

Measure	Time frame
Score of symptoms of atrophic vaginitis. Timepoint: Vaginal symptoms score will be measured before and 8 weeks after the start of the intervention. Method of measurement: For evaluation of this variable we will use of standard questionnaire.	—

Secondary

Measure	Time frame
Score of symptoms of overactive bladder syndrome. Timepoint: Score of symptoms of overactive bladder syndrome will be measured before and 8 weeks after the start of the intervention. Method of measurement: A standard questionnaire is used to measure this variable.;Satisfaction score. Timepoint: Satisfaction score of the drug will be measured 8 weeks after the start of the intervention. Method of measurement: A standard questionnaire is used to measure this variable.;Frequency of side effects. Timepoint: frequency of side effects, will be measured 8 weeks after the start of the intervention. Method of measurement: A standard questionnaire is used to measure this variable.	—

Measure

Time frame

Score of symptoms of overactive bladder syndrome. Timepoint: Score of symptoms of overactive bladder syndrome will be measured before and 8 weeks after the start of the intervention. Method of measurement: A standard questionnaire is used to measure this variable.;Satisfaction score. Timepoint: Satisfaction score of the drug will be measured 8 weeks after the start of the intervention. Method of measurement: A standard questionnaire is used to measure this variable.;Frequency of side effects. Timepoint: frequency of side effects, will be measured 8 weeks after the start of the intervention. Method of measurement: A standard questionnaire is used to measure this variable.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSevil Hakimi

Tabriz University of Medical Sciences

hakimisevil@gmail.com+98 4134790364 - 34796770

Outcome results

None listed

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