on-hormonal treatment of vaginal atrophy.
- Conditions
- vaginal atrophy.Postmenopausal Atrophic Vaginitis
- Registration Number
- IRCT2013060913611N1
- Lead Sponsor
- Mashhad Universityof Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 60
age between 40-65 years old; amenorrhea for at least 12 months, or 6 months after the last menstrual them with FSH> 40; having a normal Pap smear within the past 3 years, or more than 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy; clinical atrophy of the vagina through a set of criteria that includes: PH vagina> 5 and earn a score of 65 or higher (based on a visual analogue scale, VAS) for most bothersome symptoms (MBS) and superficial cells equal or less than 5% and at least two symptoms of Descriptive Assessment Table of Vaginal Mucosa. Exclusion criteria: existing breast or endometrial cancer or suspicion thereof, genital abnormalities; abnormal vaginal bleeding; cardiovascular disease (including coronary heart disease; cerebrovascular disease; thromboembolic disorders); active liver or gallbladder disease; diabetes and blood pressure-lowering drugs; vaginal infection; allergy to estrogen and vitamin E; hormone use during the 8 weeks before the study; the use of 40 to 60 grams phytoestrogens during the day; use of stimuli that can cause chronic itching in the vagina; useing less than 70% of the total number of drug (less than 24 times during the treatment period
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptoms of vaginal atrophy. Timepoint: Before intervention, 4, 8 and 12 weeks after intervention. Method of measurement: Description of the vaginal mucosa? vaginal maturation index, the most bothersome symptom of vaginal and vaginal pH.
- Secondary Outcome Measures
Name Time Method Superficial cells in the vagina. Timepoint: Befor the intervention? 4? 8 and 12 weeks after intervention. Method of measurement: Vaginal maturation index.