NCT02906111

Vaginal Estriol Before and Vaginal Surgery for Prolapse

Effects on Vaginal Health and Quality of Life in Postmenopausal Women Using Ultra Low Topic Estriol Before Vaginal Surgery for Pelvic Statics Disorders

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Salvatore Caruso · Academic / Other
• Sex: Female
• Age: 56 Years – 63 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the vaginal estriol before vaginal surgery for pelvic statics disorders is more efficacy of no estriol treatment on vaginal health and quality of life.

Detailed description

The aim of this randomized study was to evaluate the efficacy of low concentration of vaginal estriol gel (0.005%, 50 micrograms/1 g vaginal gel) in women with pelvic statics disorders before vaginal surgical treatment (group A), assessing the vaginal dryness, dysuria, vaginal maturation index (VMI), pH and the Vaginal Health Index (VHI). Secondary, to investigate the changes of sexual function and QoL. Women without pre surgical estriol treatment constituted the control group (group B).

Conditions

• Genital Prolapse

Interventions

Type	Name	Description
DRUG	estriol	Study Group, treated with estriol Control Group, no drug treatment Both groups will undergo vaginal surgery for prolapse
PROCEDURE	vaginal surgery	Control Group

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-09-19
• Last updated: 2016-09-19