on Hormonal Treatment of Vaginal Atrophy
Phase 2
- Conditions
- N95. 3: Vaginal Atrophy.Diseases of the genitourinary system (N00-N99)
- Registration Number
- IRCT2016100229683N2
- Lead Sponsor
- Vice chancellor for research, Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 150
Inclusion Criteria
being married; having stage 1 and 2 breast cancer based on surgery staging; use of tamoxifen; non-use of chemotherapy or radiation during this study; aged under 50 years; with at least one of the symptoms of the self-assessment urogenital atrophy questionnaire; normal Pap smear within the last 3 years; no proven cancer in other organs of the body based on the results recorded in patient records; having sexual activity.Exclusion criteria: vaginal infection (confirmed by Microbiological analysis); abnormal Pap smear; estrogen therapy during the past 8 weeks; unexplained vaginal bleeding; recurrent disease based on the diagnostic results recorded in patient records; smoking cigarette.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vaginal ph. Timepoint: Before intervention, Two weeks after the intervention, Four weeks after intervention, eight weeks after intervention. Method of measurement: PH indicator strip.
- Secondary Outcome Measures
Name Time Method Vaginal cell Maturation. Timepoint: Before intervention, eight weeks after intervention. Method of measurement: Vaginal Maturation Index.;Symptoms of vaginal atrophy. Timepoint: Before intervention, Two weeks after the intervention, Four weeks after intervention, eight weeks after intervention. Method of measurement: Self-assessment urogenital atrophy questionnaire (UAQ).