The effect of aleo vera cream on vaginal atrophy
Phase 3
- Conditions
- Post menopausal atrophic vaginitis.Postmenopausal atrophic vaginitisN95.2
- Registration Number
- IRCT20190405043170N1
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
non hysterectomized
postmenopausal with 2 or more years since final menstrual cycle
age > 40 years with urogenital symptoms ( vaginal dryness, pruritus,dyspareunia, burning and dysuria ) .
Exclusion Criteria
USING EXOGENOUS SEX HORMONE DURING 6 MONTHS BEFORE STARTING STUDY
RECENT CORTICOSTEROID USE
VAGINAL INFECTION
VAGINAL ABNORMALITY
VAGINAL BLEEDING WITH UNKNOWN ORIGIN
KNOWN OR SUSPECTED HISTORY OF HORMONE DEPENDENT TUMOR
BREAST CARCINOMA
ACUTE THROMBOEMBOLIC DISORDER ASSOCIATED WITH ESTROGEN USE
ANY SERIOUS DISEASE OR CHRONIC CONDITION SUCH AS HEPATIC DISORDER OR MODERATE TO SEVERE HTN THAT INTERFERE WITH STUDY COMPLIANCE
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of treatment satisfaction using 5-point Likert scale. Timepoint: 6 weeks after cream administration. Method of measurement: Subjectively using 5-point Likert scale.
- Secondary Outcome Measures
Name Time Method