Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients
Study Details
Study Description
Brief Summary
To evaluate the difference of three vaginal estrogens creams comparative with placebo on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Conjugated Estrogen Group use of 1 gram per day |
Drug: Promestriene
use of 1 gram per day
Other Names:
Drug: Estriol
use of 1 gram per day
Other Names:
Drug: Vaginal Moisturizer - Cream
use of 1 gram per day
Other Names:
|
Active Comparator: Promestriene Group use of 1 gram per day |
Drug: Conjugated Estrogen
use of 1 gram per day
Other Names:
Drug: Estriol
use of 1 gram per day
Other Names:
Drug: Vaginal Moisturizer - Cream
use of 1 gram per day
Other Names:
|
Active Comparator: Estriol Group use of 1 gram per day |
Drug: Conjugated Estrogen
use of 1 gram per day
Other Names:
Drug: Promestriene
use of 1 gram per day
Other Names:
Drug: Vaginal Moisturizer - Cream
use of 1 gram per day
Other Names:
|
Placebo Comparator: Vaginal Moisturizer Cream use of 1 gram per day |
Drug: Conjugated Estrogen
use of 1 gram per day
Other Names:
Drug: Promestriene
use of 1 gram per day
Other Names:
Drug: Estriol
use of 1 gram per day
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Evaluate the histopathological effects on endometrium after each treatment [48 days]
Compare the histopathological results after treatment on each group and among each other
- Compare the endometrial thickness measured by ultrassound after each treatment [48 days]
Compare the endometrial ultrasound measurement before and after treatment in each group, and among each other
Secondary Outcome Measures
- Evaluate the changes of maturation index (Meisels Index) after each treatement [48 days]
Compare the changes on Meisels Index after each treatment and among each other
- Evaluate the changes on climacteric complaints after each treatment [48 days]
Compare the changes on systemic and genital complaints after each treatment, and among each other
Eligibility Criteria
Criteria
Inclusion Criteria:
-
post menopause women
-
normal oncotic cytology and mammogram
-
any grade of pelvic organ prolapse with surgery indication and ultrasound with endometrium measure less than 5 mm
Exclusion Criteria:
-
vaginal bleeding
-
hormonal replacement on the past three months
-
renal or hepatic desease
-
porfiria
-
past venous thromboembolism; ulcerated prolapse
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Universidade Federal do ParanĂ¡
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23286013.7.0000.0096
- 475.622