Effect of Alcea in treatment of vaginal atrophy.
Phase 3
Recruiting
- Conditions
- Vaginal atrophy.Postmenopausal atrophic vaginitis
- Registration Number
- IRCT20180923041099N1
- Lead Sponsor
- Gorgan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
Married women, and have sexual activity;
Age between 40-65 years;
Complaint of vaginal dryness;
Amenorrhea for at least 12 months, or laboratory confirmation of menopause(FSH>40);
Amenorrhea after surgery and Bilateral Oophorectomy;
Exclusion Criteria
Endometrial cancer or breast cancer or suspicion of it;
Vaginal bleeding with unknown causes;
Vaginal infection;
History of sensitivity to the Alcea;
Chronic diseases;
The history of consumption of hormonal products containing estrogen and progesterone in the last month;
The history of vaginal use of stimulants that can cause chronic vaginal itching (scents, moisturizers, soaps) in the last month;
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptoms of vaginal atrophy. Timepoint: Before intervention, Eight weeks after intervention. Method of measurement: The most bothersome symptom of vaginal mucosa with Visual Analogue Scale.;Vaginal superficial cells. Timepoint: Before intervention, Eight weeks after intervention. Method of measurement: vaginal maturation index.;Vaginal PH. Timepoint: Before intervention, Eight weeks after intervention. Method of measurement: PH meter.
- Secondary Outcome Measures
Name Time Method Sexual satisfaction. Timepoint: Before intervention, Eight weeks after intervention. Method of measurement: Standard Questionnaire for Assessment of Female Sexual function (FSFI).