on Hormonal Treatment of Vaginal Atrophy
Phase 3
- Conditions
- Vaginal Atrophy.Postmenopausal Atrophic Vaginitis
- Registration Number
- IRCT201105026364N1
- Lead Sponsor
- Vice chancellor for research, Jondi Shapur Ahvaz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
Age between 45 to 65, Amenorrhea at less 12 month or have hormone test with FSH level more than 40 unit, Presence of normal pap smears, Presenting symptom of vaginal atrophy, Vaginal pH more than 5, Superficial vaginal cells with 5% or less, Have Sexual activity
Exclusion criteria: Vaginal infection, Genital Abnormalities, The use of Sex Hormones within the 8 weeks preceding study, Genital Bleeding of unknown Cause, Use of Phytoestrogens such as Soy, Red clover, Fenugreek, Vitex within the last one
Month
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptoms of Vaginal Atrophy. Timepoint: Before intervention, Two weeks after the intervention, Four weeks after intervention, Eight weeks after intervention. Method of measurement: Composite Score of Vaginal Symptoms.
- Secondary Outcome Measures
Name Time Method Vaginal Superficial Cells. Timepoint: after intervention, Two months after intervention. Method of measurement: Vaginal Cells Maturation Index.;Vaginal pH. Timepoint: Before intervention, Two months after intervention. Method of measurement: pH Test.