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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150424021917N7

Enrollment

Registered

2018-02-10

Start date

2018-02-20

Completion date

Unknown

Last updated

2018-03-26

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: ?They will received vaginal cream of fenugreek extract 5%, 0.5 gram or half of applicator twice per week for 12 weeks. Intervention 2: Control group: They will rece

Eligibility

Sex/Gender

Female

Age

45 Years to 55 Years

Inclusion criteria

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

Exclusion criteria

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,

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSevil Hakimi

Tabriz University of Medical Sciences

hakimis@tbzmed.ac.ir+98 41347797777

Outcome results

None listed

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