Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients

April 29, 2019 updated by: Elisa Chicareli Pinhat, Universidade Federal do Paraná

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 4

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • post menopause women
  • normal oncotic cytology and mammogram
  • any grade of pelvic organ prolapse with surgery indication and ultrasound with endometrium measure less than 5 mm

Exclusion Criteria:

  • vaginal bleeding
  • hormonal replacement on the past three months
  • renal or hepatic desease
  • porfiria
  • past venous thromboembolism; ulcerated prolapse

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conjugated Estrogen Group
use of 1 gram per day
Drug: Promestriene
use of 1 gram per day
Other Names:
  • Colpotrofine
Drug: Estriol
use of 1 gram per day
Other Names:
  • Stelle
Drug: Vaginal Moisturizer - Cream
use of 1 gram per day
Other Names:
  • Vagidrat
Active Comparator: Promestriene Group
use of 1 gram per day
Drug: Estriol
use of 1 gram per day
Other Names:
  • Stelle
Drug: Vaginal Moisturizer - Cream
use of 1 gram per day
Other Names:
  • Vagidrat
Drug: Conjugated Estrogen
use of 1 gram per day
Other Names:
  • Premarin
Active Comparator: Estriol Group
use of 1 gram per day
Drug: Promestriene
use of 1 gram per day
Other Names:
  • Colpotrofine
Drug: Vaginal Moisturizer - Cream
use of 1 gram per day
Other Names:
  • Vagidrat
Drug: Conjugated Estrogen
use of 1 gram per day
Other Names:
  • Premarin
Placebo Comparator: Vaginal Moisturizer Cream
use of 1 gram per day
Drug: Promestriene
use of 1 gram per day
Other Names:
  • Colpotrofine
Drug: Estriol
use of 1 gram per day
Other Names:
  • Stelle
Drug: Conjugated Estrogen
use of 1 gram per day
Other Names:
  • Premarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 days
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
48 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 days
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
48 days

Collaborators and Investigators

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

Sponsor

Universidade Federal do Paraná

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 (Actual)

November 26, 2013

Primary Completion (Actual)

December 20, 2016

Study Completion (Actual)

December 26, 2016

Study Registration Dates

First Submitted

January 20, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23286013.7.0000.0096
  • 475.622 (Registry Identifier: Opinion Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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