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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 July 2016 |
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Main ID: |
NCT02419729 |
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Date of registration:
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06/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Fractional CO2 Laser Treatment Efficacy and Comparison to Vaginal Estrogen Therapy in Postmenopausal Women With Vulvovaginal Atrophy
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Scientific title:
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Evaluation of Fractional CO2 Laser Treatment Efficacy and Comparison to Vaginal Estrogen Therapy in Postmenopausal Women With Vulvovaginal Atrophy |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02419729 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Vera L da Cruz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculdade de Medicina do ABC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 45-65 women with amenorrhea for over 24 months.
- Clinical vaginal atrophy diagnosis.
Exclusion Criteria:
- BMI > 35.
- Previous use of oral estrogen therapy in the last 6 months.
- History or current diagnosis of cancer.
- Altered cervical smear in the last 12 months.
- Renal or hepatic insufficiency.
- Drug-induced menopause.
- Previous use of steroids.
- Previous vaginal radiotherapy therapy.
- Vulvovaginitis.
Age minimum:
45 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Vulvovaginal Atrophy
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Intervention(s)
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Drug: Estrogen
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Device: CO2 laser
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Drug: Placebo of Estrogen
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Device: Placebo of CO2 laser
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Primary Outcome(s)
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Change from Baseline in Vulvovaginal Symptom Questionnaire
[Time Frame: Baseline, week 10 and week 17]
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Secondary Outcome(s)
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Change from Baseline in Female Sex Function Index
[Time Frame: Baseline, week 10 and week 17]
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Change from Baseline in The Menopause-Specific Quality of Life
[Time Frame: Baseline, week 10 and week 17]
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Vaginal Cytology Improvement
[Time Frame: Baseline, week 10 and week 17]
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Secondary ID(s)
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39495014.0.0000.0082
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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