Clinical Trial: Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Universidade Federal do Paraná

Current Primary Outcome:

• Evaluate the histopathological effects on endometrium after each treatment [ Time Frame: 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 [ Time Frame: 48 days ]
  Compare the endometrial ultrasound measurement before and after treatment in each group, and among each other

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Evaluate the changes of maturation index (Meisels Index) after each treatement [ Time Frame: 48 days ]
  Compare the changes on Meisels Index after each treatment and among each other
• Evaluate the changes on climacteric complaints after each treatment [ Time Frame: 48 days ]
  Compare the changes on systemic and genital complaints after each treatment, and among each other

Original Secondary Outcome: Same as current

Information By: Universidade Federal do Paraná

Dates:
Date Received: January 20, 2017
Date Started: November 26, 2013
Date Completion:
Last Updated: January 23, 2017
Last Verified: January 2017