Comparison of fenufreek extract vaginal cream with ultra low dose conjugated estrogen vaginal cream on atrophic vaginitis.

Phase 3

Recruiting

• Conditions: Atrophic Vaginitis.; Senile (atrophic) vaginitis

• Registration Number: IRCT20150424021917N7
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Menopausal women
Physiologic menopasue
Having sexual avtivity
?Affected by atrophic vaginitis

Exclusion Criteria

Vaginal bleeding
Hormone replacement therapy during last 3 months
History of breast cancer or ant type of estrogen dependent cancer
History of breast cancer in first grade relatives (ex. mother, sister)
Estrogen contraindication including history of vein thrombosis, any type of vascular disease, thrombophlebitis,

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal symptoms score. Timepoint: Vaginal symptoms score will be measured before and 12 weeks after start id intervention. Method of measurement: For evaluation of this variable we will use of standard questionnare.;Vaginal maturation index is the second main outcome. Timepoint: Vaginal maturation index will be measured before and 12 weeks after start id intervention. Method of measurement: This index is indicated to proportion of parabasal, intermediate and superficial cellules . We will taken pap smear from participants. Percent of superficial cellules will be multiply in 1, percent of intermediate cellules will be multiply in 0.5 and percent of parabasal cellules will be multiply in 0. After that all of numbers will be summed.

Secondary Outcome Measures

Name	Time	Method
Vaginal pH. Timepoint: Before and 12 weeks after intervention. Method of measurement: Vaginal pH will be measured with using of pH meter kits.;Satisfaction from treatment. Timepoint: 12 weeks after start of intervention. Method of measurement: With using of questionnare.