MedPath

Phytoestrogenic treatment of vaginal atrophy in postmenopausal wome

Phase 3
Recruiting
Conditions
Vaginal Atrophy.
Postmenopausal atrophic vaginitis
Registration Number
IRCT20171224038036N2
Lead Sponsor
Ahvaz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
76
Inclusion Criteria

Age range from 45 to 65 years
Women with at least one year of menstruation or having a hormonal test with an FSH level higher than 40 international units with a spouse
Having sexual activity
The presence of vaginal atrophy

Exclusion Criteria

Vaginal bleeding with unknown cause
Vaginal infection
Hormone therapy or use of sex hormones 8 weeks before study
Taking isoflavones in the diet
History of suspected breast mass or breast cancer
Hospital admission during research
Unwillingness to continue the study company

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Vaginal atrophy. Timepoint: Before intervention, after intervention. Method of measurement: Vaginal smear.
Secondary Outcome Measures
NameTimeMethod
Dyspareunia. Timepoint: Before the intervention, two weeks after the intervention, four weeks after the intervention, eight weeks after the intervention. Method of measurement: 4 degree self-rating scale.;Sexual performance. Timepoint: Before and after intervention. Method of measurement: Female Sexual Function Index (FSFI).;Sexual satisfaction. Timepoint: Before and after the intervention. Method of measurement: Larsson Sexual Satisfaction Questionnaire.;Severity of menopause symptoms. Timepoint: Before the intervention, two, four, and eight weeks after the intervention. Method of measurement: Menopause Rating Scale Questionnaire.
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