Vaginitis Atropic, Pelvic Organ Prolapse, Endometrial Hyperplasia
Conditions
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.
Interventions
use of 1 gram per day
DRUGPromestriene
use of 1 gram per day
DRUGEstriol
use of 1 gram per day
DRUGVaginal Moisturizer - Cream
use of 1 gram per day
Sponsors
Universidade Federal do Paraná
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed