Trial | NCT02906111  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    estriol ...

  • Study Participants

    88
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.
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).
Study Started
Nov 30
2016
Primary Completion
Jun 30
2017
Anticipated
Study Completion
Jun 30
2017
Anticipated
Last Update
Sep 19
2016
Estimate

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

  • Other names: vaginal surgery for prolapse

Study Group on estriol vaginal gel Active Comparator

Drug: 1 g/daily of vaginal gel containing 50 μg of estriol (0.005%) for 3 weeks and then twice weekly for 9 weeks, for a complete cycle of treatment of 12 weeks

Control group, no estriol treatment Active Comparator

Procedure: vaginal surgery

Criteria 

Inclusion Criteria:

genital dryness,
irritation/burning/itching of vulvas or vagina
decreased lubrication with sexual activity
discomfort or pain with sexual activity
decreased arousal, orgasm, desire
dysuria.

Exclusion Criteria:

previous surgeries for pelvic organ prolapse
urinary incontinence
usage of medication
chronic medical illness
body mass index (BMI) ≥ 35 kg/m2
endometrial thickness equal to or greater than 4 mm
abnormal uterine bleeding
hormone-dependent malignancies
history of thromboembolic disease
liver disease
usage of HT for less than 3 months
usage of phytoestrogens within 1 month before the start of the study
partner affected by sexual disorder
conflicting with the partner
No Results Posted