The effects of vaginal estrogen therapy, moisturizers, and lubricants on the number of lactobacilli in postmenopausal vaginal atrophy
- Conditions
- Vaginal atrophyvaginal atrophypostmenopausevaginal estrogen therapyvaginal moisturizervaginal lubricant
- Registration Number
- TCTR20160426005
- Lead Sponsor
- Ratchadaphiseksomphot Endowment fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 99
-Naturally postmenopausal women aged 45-70 years old (using WHO criteria for retrospective amenorrhea for 12 months after final menstruation with no obvious pathological cause of amenorrhea)
-At least one clinical symptom of vaginal atrophy, with moderate to severe intensity
-Vaginal pH > 5
-Menopause from other causes (POI, hysterectomy, oophorectomy, chemotherapy, radiation)
-History of vaginal or cervical procedures within the previous 3 months (LEEP, conization, cryotherapy)
-Recurrent or recent vaginal inflammation or related infection within the previous 3 months
-History of hormone replacement therapy, use of vaginal lubricants or local estrogen therapy within the previous 3 months
-Abnormal vaginal bleeding within the previous 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of lactobacilli first visit and 8 weeks after treatment gram stain technique and 1000x microscopic
- Secondary Outcome Measures
Name Time Method vaginal pH first visit and 8 weeks after treatment pH indicator strips,the most bothersome symptom first visit and 8 weeks after treatment the most bothersome symptom score,Species of lactobacilli 8 weeks after treatment Anaerobe Culture,Vaginal maturation index first visit and 8 weeks after treatment H&E stain and count the vaginal cells