Vaginal Estriol Before and Vaginal Surgery for Prolapse (VSaE)

September 14, 2016 updated by: Salvatore Caruso

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Salvatore Caruso, Prof
  • Phone Number: +390953781101
  • Email: scaruso@unict.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

54 years to 61 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study Group on estriol vaginal gel
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
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
Active Comparator: Control group, no estriol treatment
Procedure: vaginal surgery
Procedure: vaginal surgery
Control Group
Other Names:
  • vaginal surgery for prolapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vaginal Health Indexes
Time Frame: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
QoL and sexual function were investigated by the Short Form 36 (SF-36)
Time Frame: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12), respectively
Time Frame: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salvatore Caruso

Investigators

  • Study Chair: Antonio Cianci, Prof, Policlinico Catania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Estimate)

September 19, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MenSurgE2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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