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Vaginal gel Chamomile and Conjugated Estrogen in the treatment of vaginal atrophy

Phase 3
Recruiting
Conditions
Vaginal Atrophy in Postmenopausal Women.
Postmenopausal atrophic vaginitis
Registration Number
IRCT20171218037943N1
Lead Sponsor
Ahvaz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
96
Inclusion Criteria

People who have had at least one year of their last menstruation or have a hormonal test with an average fsh> 40 international units
There are symptoms of vaginal atrophy
The age range is 45-65 years
Have sex and monogamy

Exclusion Criteria

Vaginal infection needs treatment
Genital abnormalities
Hormone therapy or use of sexual hormones during the 8 weeks prior to the study
Using vaginal medicines or any lubricant at least 15 days before the study
Tobacco use (alcohol, cigarette and hookah)
Breast diseases with unknown cause
Uterine bleeding or spotting with unspecified cause
Excessive consumption of phytoestrogens such as soy, red clover, fenugreek over the past month
BMI more than 30
Cholestatic Diseases of the Liver
Severe kidney failure
Acute Thrombophlebitis
High blood pressure

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Vaginal atrophy. Timepoint: At the beginning of the study, 14, 42 and 84 days after Intervention. Method of measurement: Cooperman Index Questionnaire.;Percentage of vaginal cell maturation. Timepoint: Before intervention, after intervention. Method of measurement: Vaginal smear.;Vaginal acidity. Timepoint: Before intervention, after intervention. Method of measurement: PH gauge.
Secondary Outcome Measures
NameTimeMethod
Painful intercourse. Timepoint: At the beginning of the study, 14, 42 and 84 days after Intervention. Method of measurement: Self-assessment scale is 4 degrees.;Menopause symptoms. Timepoint: At the beginning of the study, 14, 42 and 84 days after Intervention. Method of measurement: Cooperman Index Questionnaire.;Severity of menopause symptoms. Timepoint: At the beginning of the study, 14, 42 and 84 days after Intervention. Method of measurement: Menopause Rating Scale.;Sexual performance. Timepoint: Before and after the intervention. Method of measurement: Female Sexual Function Index (FSFI).;Sexual satisfaction. Timepoint: Before and after the intervention. Method of measurement: Larson Sexual Satisfaction Questionnaire.
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