Comparison of the Effectiveness of Vaginal Cream contain extract of Foenicolum vulgar; Salvia officinalis. L; Flaxseed; on Vaginal atrophy in postmenopausal Wome
Phase 3
- Conditions
- Vaginal Atrophy in Postmenopausal Women.Postmenopausal atrophic vaginitisN95.2
- Registration Number
- IRCT20190616043909N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
Age between 45 to 65; Amenorrhea at less 12 month or have hormone test with FSH level more than 40 unit; Presenting symptom of vaginal atrophy; Have Sexual activity and single partner;
Exclusion Criteria
Genital abnormalities; breast diseases with unknown reason; liver cholestatic disorders; renal failure; vaginal infection needing treatment; genital bleeding or spotting with unknown reason; hormone therapy or using sex hormones within the 2 months before the study; using of phytoestrogens such as soy, red clover, fenugreek, and vitex within the last one month; body mass index more than 30 .
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptom of vaginal atrophy. Timepoint: At the beginning of the study, 4 weeks and 8 weeks after intervention. Method of measurement: The most bothersome symptom cheklist.;Clinical signs of vaginal atrophy. Timepoint: At the beginning of the study, 2 weeks, 4 weeks and 8 weeks after intervention. Method of measurement: Check list of clinical signs of vaginal atrophy.;Vaginal maturation index. Timepoint: Before intervention and after intervention. Method of measurement: Vaginal Smear.;Vaginal acidity. Timepoint: Before intervention and after intervention. Method of measurement: PH meter.
- Secondary Outcome Measures
Name Time Method Sexual function. Timepoint: Before and after intervention. Method of measurement: Female Sexual Function Index (FSFI) questionnaire.