Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Blinded Trial Comparing Vaginal Estrogens on Pelvic Organ Prolapse Patients

Conditions
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Vaginitis Atropic, Pelvic Organ Prolapse, Endometrial Hyperplasia

Intervention / Treatment
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* Drug: Conjugated Estrogen
* Drug: Promestriene
* Drug: Estriol
* Drug: Vaginal Moisturizer - Cream


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conjugated Estrogen Group<br>use of 1 gram per day | Drug: Promestriene<br>* use of 1 gram per day<br>* Other names: Colpotrofine;Drug: Estriol<br>* use of 1 gram per day<br>* Other names: Stelle;Drug: Vaginal Moisturizer - Cream<br>* use of 1 gram per day<br>* Other names: Vagidrat;|
| Active Comparator: Promestriene Group<br>use of 1 gram per day | Drug: Conjugated Estrogen<br>* use of 1 gram per day<br>* Other names: Premarin;Drug: Estriol<br>* use of 1 gram per day<br>* Other names: Stelle;Drug: Vaginal Moisturizer - Cream<br>* use of 1 gram per day<br>* Other names: Vagidrat;|
| Active Comparator: Estriol Group<br>use of 1 gram per day | Drug: Conjugated Estrogen<br>* use of 1 gram per day<br>* Other names: Premarin;Drug: Promestriene<br>* use of 1 gram per day<br>* Other names: Colpotrofine;Drug: Vaginal Moisturizer - Cream<br>* use of 1 gram per day<br>* Other names: Vagidrat;|
| Placebo Comparator: Vaginal Moisturizer Cream<br>use of 1 gram per day | Drug: Conjugated Estrogen<br>* use of 1 gram per day<br>* Other names: Premarin;Drug: Promestriene<br>* use of 1 gram per day<br>* Other names: Colpotrofine;Drug: Estriol<br>* use of 1 gram per day<br>* Other names: Stelle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the histopathological effects on endometrium after each treatment | Compare the histopathological results after treatment on each group and among each other | 48 days | 
| Compare the endometrial thickness measured by ultrassound after each treatment | Compare the endometrial ultrasound measurement before and after treatment in each group, and among each other | 48 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the changes of maturation index (Meisels Index) after each treatement | Compare the changes on Meisels Index after each treatment and among each other | 48 days | 
| Evaluate the changes on climacteric complaints after each treatment | Compare the changes on systemic and genital complaints after each treatment, and among each other | 48 days |