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Vaginal Estriol Before and Vaginal Surgery for Prolapse (VSaE)

This study is not yet open for participant recruitment.
Verified September 2016 by Salvatore Caruso, Policlinico Universitario, Catania
Sponsor:
ClinicalTrials.gov Identifier:
NCT02906111
First Posted: September 19, 2016
Last Update Posted: September 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Salvatore Caruso, Policlinico Universitario, Catania
  Purpose
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.

Condition Intervention Phase
Genital Prolapse Drug: estriol Procedure: vaginal surgery Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects on Vaginal Health and Quality of Life in Postmenopausal Women Using Ultra Low Topic Estriol Before Vaginal Surgery for Pelvic Statics Disorders

Resource links provided by NLM:


Further study details as provided by Salvatore Caruso, Policlinico Universitario, Catania:

Primary Outcome Measures:
  • Vaginal Health Indexes [ Time Frame: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]

Estimated Enrollment: 88
Study Start Date: November 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: vaginal surgery for prolapse
Active Comparator: Control group, no estriol treatment
Procedure: vaginal surgery
Procedure: vaginal surgery
Control Group
Other Name: vaginal surgery for prolapse

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).
  Eligibility

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Ages Eligible for Study:   56 Years to 63 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906111


Contacts
Contact: Salvatore Caruso, Prof +390953781101 scaruso@unict.it

Sponsors and Collaborators
Salvatore Caruso
Investigators
Study Chair: Antonio Cianci, Prof Policlinico Catania
  More Information

Publications:
Responsible Party: Salvatore Caruso, Professor of Gynecology, Clinic of Gynecology, Policlinico Universitario, Catania
ClinicalTrials.gov Identifier: NCT02906111     History of Changes
Other Study ID Numbers: MenSurgE2
First Submitted: August 24, 2016
First Posted: September 19, 2016
Last Update Posted: September 19, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Salvatore Caruso, Policlinico Universitario, Catania:
Estriol
Prolapse
Quality of life
Vaginal health
Vaginal surgery

Additional relevant MeSH terms:
Prolapse
Pathological Conditions, Anatomical